Your production schedule just got derailed by an FDA inspection observation. Your quality team is scrambling to understand why procedures you’ve followed for years suddenly don’t meet current Good Manufacturing Practice requirements. And now you’re facing questions from executives about potential warning letters and what they mean for your business.
I’ve seen this pattern repeatedly across food and dietary supplement manufacturers. They invest in quality systems, train their staff, and genuinely attempt compliance. But FDA compliance mistakes still happen because companies treat regulations as static checklists rather than evolving standards that require continuous verification against current agency expectations.
This article identifies the most common FDA compliance mistakes, explains the real-world consequences companies face when these errors occur, and clarifies when specialized legal guidance prevents enforcement escalation.
Misunderstanding Current Good Manufacturing Practice Requirements
Current Good Manufacturing Practice regulations form the foundation of FDA compliance for food and dietary supplement manufacturers. Yet CGMP violations appear in the majority of FDA warning letters – not because companies ignore regulations, but because they misunderstand what “current” actually means.
Treating CGMPs as Fixed Standards
The word “current” in CGMP isn’t decorative. It means manufacturing practices must reflect present-day standards of quality, not what was acceptable when you first established your procedures.
FDA evaluates your manufacturing practices against current industry standards, available technology, and scientific understanding. A cleaning procedure that satisfied inspectors five years ago may not meet current expectations if new sanitation technologies or methods have become standard practice.
This dynamic standard trips up established manufacturers who believe their FDA-inspected procedures are permanently approved. One West Coast dietary supplement manufacturer discovered this during a 2023 inspection when FDA cited their environmental monitoring program as inadequate. The company had an environmental monitoring program – they’d implemented it years earlier and inspectors had previously accepted it. But current industry standards expected more comprehensive sampling, specific indicator organisms, and trend analysis that their program didn’t include. The resulting warning letter cited CGMP violations for a program the company believed was compliant.
Inadequate Master Manufacturing Records
Master manufacturing records must contain complete instructions for producing products consistently. Yet many companies maintain MMRs that lack critical specifications, process parameters, or quality control procedures.
An inadequate MMR doesn’t just violate CGMP regulations – it means you can’t actually verify whether your production follows established procedures. When FDA inspectors compare batch records against your MMR, gaps in the MMR make it impossible to determine compliance.
Common MMR deficiencies include missing critical process parameters, vague quality control acceptance criteria, incomplete equipment specifications, and absent cleaning procedures. Each deficiency represents a CGMP violation that FDA will document during inspections.
Insufficient Process Validation
FDA expects manufacturers to validate that their processes consistently produce products meeting predetermined quality standards. Process validation failures represent one of the most serious CGMP violations.
Many companies confuse verification with validation. Running a few successful batches doesn’t constitute validation. True process validation requires documented evidence from a scientifically sound protocol that the process consistently meets specifications.
A Midwest food manufacturer learned this distinction through enforcement action. They’d been producing products for years with no consumer complaints or quality issues. But when FDA inspected, they couldn’t produce process validation studies demonstrating their thermal processing actually achieved the lethality they claimed. FDA issued a warning letter citing inadequate process validation and required the company to conduct comprehensive validation studies before continuing production of shelf-stable products.
Mishandling Product Complaints and Adverse Events
How companies handle complaints and adverse events directly affects FDA compliance. Inadequate complaint handling appears frequently in warning letters and indicates broader quality system failures.
Failing to Investigate Complaints Adequately
FDA requires manufacturers to review and investigate product complaints. Many companies receive this requirement but don’t grasp how thoroughly FDA expects them to investigate.
A cursory review that concludes “customer misused product” doesn’t satisfy FDA expectations. Your investigation must determine whether the complaint represents a product defect, identify the root cause if a defect exists, and evaluate whether corrective action is necessary.
Documentation matters as much as the investigation itself. FDA wants to see what you investigated, what you found, and what you concluded. Complaint records that simply state “investigated, no action needed” don’t demonstrate adequate investigation.
One dietary supplement company received a warning letter after FDA found their complaint files contained minimal investigation documentation. When customers reported adverse events, the company had documented receiving the complaints but showed no evidence of investigating whether their products caused the events. FDA cited failure to investigate complaints and failure to review adverse events – violations that suggested the company’s quality system wasn’t functioning.
Not Reporting Serious Adverse Events
Dietary supplement and food companies must report serious adverse events to FDA within specific timeframes. Failure to report constitutes a serious compliance violation that can trigger criminal investigation.
The reporting requirement applies when you receive information that reasonably suggests your product caused a serious adverse event. Companies make the mistake of deciding the product couldn’t have caused the event and therefore they don’t need to report. That’s not how the requirement works.
FDA expects you to report first and investigate later. The agency will evaluate whether your product actually caused the event. Your job is to recognize when you’ve received reportable information and submit it within 15 business days.
Ignoring Complaint Trends
Individual complaints might seem insignificant, but patterns of similar complaints indicate potential quality problems. FDA expects manufacturers to analyze complaint trends and take action when patterns emerge.
Companies that treat each complaint as an isolated incident miss opportunities to identify systemic issues. If you’re receiving repeated complaints about product appearance, taste, or packaging integrity, those patterns warrant investigation into your manufacturing processes.
Documentation and Record-Keeping Failures
FDA inspections focus heavily on documentation. Inspectors evaluate your actual practices through the records you maintain. Documentation failures make it impossible to demonstrate compliance even when your actual practices are sound.
Incomplete or Inaccurate Batch Records
Batch production records must document that you followed your master manufacturing record. Incomplete batch records represent one of the most common CGMP violations.
Missing signatures, blank fields, or entries that don’t match your MMR all constitute violations. FDA inspectors meticulously compare batch records to MMRs looking for discrepancies. Any gap suggests you either didn’t follow procedures or didn’t document that you did.
A Southeast food processor faced this issue when FDA inspection revealed numerous incomplete batch records. Critical processing parameters weren’t recorded, quality control checks were missing signatures, and some records showed timing that didn’t align with the plant’s actual production schedule. The warning letter cited multiple CGMP violations related to batch record inadequacies and required the company to implement comprehensive documentation training and oversight procedures.
Backdating or Falsifying Records
This compliance mistake crosses from negligence into fraud territory. Creating records after the fact or falsifying data to show compliance represents willful misconduct that can trigger criminal prosecution.
FDA investigators can identify backdated records through various means – ink analysis, computer metadata, cross-referencing with other records, or inconsistencies in the records themselves. When they find evidence of falsification, the consequences extend far beyond warning letters.
Companies sometimes rationalize that they know they followed procedures even though they forgot to document it at the time. Creating that documentation later still constitutes falsification. Your records must reflect what actually happened when it happened.
Inadequate Record Retention
FDA regulations specify retention periods for different record types. Companies that don’t maintain records for the required periods violate CGMP requirements and can’t demonstrate historical compliance.
The retention period often extends beyond the product’s expiration date. For products with two-year shelf life, you might need to maintain records for three years or more. Prematurely destroying records eliminates your ability to investigate complaints or respond to FDA inquiries about distributed products.
Laboratory Testing and Quality Control Errors
Your laboratory testing program validates that products meet specifications. Errors in how you conduct or document testing create compliance vulnerabilities.
Using Invalid Test Methods
FDA expects test methods to be scientifically valid and appropriate for what you’re testing. Using methods that can’t actually detect contaminants or verify specifications violates CGMP requirements.
Many companies use methods they’ve always used without verifying the methods actually work for their specific products. Method validation demonstrates that your test method reliably produces accurate results for your particular application.
A California dietary supplement manufacturer faced enforcement when FDA found their microbial testing methods couldn’t detect organisms at the levels required by their specifications. The company had been using standard methods but hadn’t validated that those methods worked with their specific product matrices. Their testing program gave false assurance that products met microbial specifications when testing couldn’t actually make that determination.
Out-of-Specification Results Not Properly Investigated
When testing produces out-of-specification results, you must investigate before releasing product. Yet companies often mishandle OOS results by dismissing them as laboratory error or retesting until they get passing results.
FDA expects thorough investigation of OOS results to determine whether they represent true product failures or laboratory errors. Simply retesting and using passing results violates CGMP requirements if you haven’t determined why the initial test failed.
The investigation must be documented with conclusions supported by evidence. If you determine a test failed because of laboratory error, your documentation must show what error occurred and why you concluded the error didn’t indicate product problems.
Inadequate Reserve Sample Programs
Reserve samples allow you to investigate complaints or quality problems after product distribution. Inadequate reserve sample programs appear regularly in FDA warning letters.
Your reserve samples must be representative of the distributed product, stored under conditions that maintain their integrity, and retained for specific periods. Companies make mistakes by not maintaining sufficient quantities, storing samples improperly, or discarding samples before retention periods expire.
Supply Chain and Ingredient Control Failures
You’re responsible for the safety and quality of ingredients you use, even when supplied by others. Supply chain control failures create significant FDA compliance risks.
Inadequate Supplier Qualification
FSMA’s Preventive Controls regulations require risk-based supplier verification. Companies can’t simply accept supplier certificates of analysis without evaluating whether suppliers actually control the hazards associated with their materials.
Supplier qualification should include evaluating the supplier’s food safety systems, reviewing relevant certifications, and determining what verification activities you need to conduct. A certificate of analysis from an unqualified supplier doesn’t satisfy your verification obligations.
FDA has cited numerous companies for inadequate supplier programs when inspections revealed they hadn’t evaluated supplier qualifications, hadn’t established appropriate verification activities, or couldn’t demonstrate they were actually conducting stated verification.
Accepting Ingredients Without Identity Verification
You must verify the identity of ingredients before using them in production. Yet many manufacturers rely entirely on supplier labels without conducting identity testing.
Economic adulteration of ingredients continues to occur throughout the supply chain. Companies that don’t verify ingredient identity risk incorporating adulterated materials into their products – creating both food safety risks and regulatory violations.
One national food manufacturer discovered this problem when testing revealed their products contained undeclared allergens that weren’t listed on ingredient supplier labels. The supplier had substituted ingredients without notifying the manufacturer, and the manufacturer’s lack of identity testing meant they didn’t detect the substitution until FDA sampling identified the problem. The resulting recall and warning letter could have been prevented through adequate incoming material testing.
Insufficient Foreign Supplier Verification
The Foreign Supplier Verification Program imposes specific requirements on importers. Companies importing food or ingredients must have FSVP procedures that verify foreign suppliers are producing food that meets U.S. safety standards.
FSVP compliance requires more than collecting certificates. You must evaluate hazards associated with imported foods, evaluate your foreign supplier’s performance, and conduct appropriate verification activities that might include supplier audits, sampling and testing, or review of food safety records.
FDA has increasingly focused enforcement attention on FSVP compliance. Warning letters cite companies that don’t have FSVP procedures, don’t conduct required hazard analyses, or don’t perform adequate supplier verification activities.
Preventive Controls and Food Safety Plan Deficiencies
FSMA’s Preventive Controls regulations transformed food safety compliance by requiring proactive hazard prevention. Yet preventive controls violations appear frequently in FDA enforcement actions because companies misunderstand what constitutes adequate food safety plans.
Inadequate Hazard Analysis
Your hazard analysis forms the foundation of your food safety plan. An inadequate hazard analysis means your entire preventive controls system might not address actual food safety risks.
FDA expects comprehensive hazard analysis that considers all known or reasonably foreseeable biological, chemical, and physical hazards. You must evaluate each hazard to determine whether it requires a preventive control.
Companies make mistakes by conducting superficial hazard analyses that miss significant hazards or dismiss hazards without adequate justification. If you determine a hazard doesn’t require a preventive control, your documentation must explain why based on the nature of the hazard, your process, or your product characteristics.
A Rocky Mountain food processor received a warning letter when FDA found their hazard analysis had dismissed pathogen contamination risks without adequate justification. The company’s products supported pathogen growth, but their hazard analysis concluded controls weren’t necessary based on assumptions about storage conditions they couldn’t actually control. FDA required a comprehensive hazard re-analysis and implementation of preventive controls to address the uncontrolled hazards.
Missing or Inadequate Preventive Controls
When hazard analysis identifies hazards requiring controls, you must implement preventive controls that minimize or prevent those hazards. The controls must be appropriate for the specific hazards you’ve identified.
Process controls, allergen controls, sanitation controls, supply chain controls, and other preventive controls must be specifically designed to address identified hazards. Generic procedures that don’t actually control your specific hazards don’t satisfy the regulations.
FDA has cited companies for having preventive controls that couldn’t actually prevent the identified hazards. For example, stating you have an allergen control program when you lack procedures to prevent cross-contact doesn’t constitute an adequate preventive control.
Failure to Conduct Required Verification Activities
Preventive controls must be verified to ensure they’re working as intended. Verification includes activities like calibration, product testing, environmental monitoring, and records review.
Many companies implement preventive controls but fail to conduct adequate verification. If you have a sanitation control to prevent pathogen contamination, verification might include environmental monitoring to confirm your sanitation program prevents pathogen establishment. Without verification, you can’t demonstrate your controls are effective.
Unqualified Preventive Controls Qualified Individual
Your food safety plan must be prepared by a Preventive Controls Qualified Individual – someone with specific training and experience. Companies violate this requirement by having unqualified individuals develop or oversee their food safety plans.
The PCQI must have successfully completed training or have job experience that qualifies them. Simply appointing your quality manager as PCQI without verifying their qualifications doesn’t satisfy the requirement.
Labeling Compliance Mistakes
Product labeling creates multiple compliance obligations. Labeling violations can result in products being considered misbranded – a serious regulatory violation with significant consequences.
Undeclared Allergens
Allergen labeling violations represent the most serious labeling compliance mistake. Products containing major food allergens must declare them clearly on the label.
The Food Allergen Labeling and Consumer Protection Act requires clear allergen declarations for milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Your label must identify the specific allergen source – for example, “tree nuts (almonds)” rather than just listing an ingredient name that might not clearly convey the allergen.
Undeclared allergen recalls occur regularly when companies fail to update labels after formulation changes, use shared equipment without adequate controls, or don’t properly declare allergen-containing ingredients.
These recalls often result in Class I classification because undeclared allergens present serious health risks to allergic consumers. The FDA response typically includes warning letters, mandatory recall effectiveness checks, and intensified future inspections.
Unauthorized Health Claims or Nutrient Content Claims
Making health claims or nutrient content claims without proper substantiation violates FDA regulations. These violations can also cause your product to be regulated as an unapproved drug if claims suggest treating or preventing disease.
Companies often don’t recognize that statements on their labels constitute impermissible claims. Terms like “healthy,” “good source of,” or “reduced” have specific regulatory definitions. Using these terms without meeting the criteria creates labeling violations.
Structure-function claims on dietary supplements require notification to FDA and specific disclaimers. Disease claims turn dietary supplements into unapproved drugs subject to drug regulations. The line between permissible and impermissible claims requires careful evaluation.
Net Quantity and Principal Display Panel Violations
Technical labeling requirements for net quantity statements, principal display panels, and information panel placement seem minor but constitute clear violations when not met.
Net quantity declarations must meet specific type size requirements based on the principal display panel area. The statement must appear in the bottom 30% of the label. These technical requirements exist to ensure consumers can easily identify product quantity.
FDA has issued warning letters for net quantity violations when companies failed to meet type size requirements or placed statements in wrong locations. While these seem like minor technical issues, they represent misbranding that can support broader enforcement action.
Country of Origin Violations
Imported products must bear country of origin marking. Domestic products making origin claims must support those claims with adequate records.
“Made in USA” claims require that all or virtually all ingredients and processing occur in the United States. Companies that make these claims without adequate substantiation face enforcement from both FDA and Federal Trade Commission.
Facility Registration and Prior Notice Failures
Administrative requirements like facility registration and prior notice seem straightforward but create compliance problems when companies don’t understand the specific obligations.
Failure to Register or Update Facility Registration
Food facilities must register with FDA and renew registration biennially. Facilities that fail to register or maintain current registration cannot legally distribute food products.
Registration updates are required when ownership changes, facility names change, or you add new food product categories. Companies that don’t maintain current registration face administrative detention of products and potential additional enforcement.
Inadequate Prior Notice for Imports
Food imports require electronic prior notice to FDA before arrival. Inadequate prior notice results in FDA refusing entry of the products.
The prior notice must include specific information about the food, its origin, the shipper, and the anticipated arrival. Missing information or inaccurate prior notice causes delays and can indicate broader compliance issues to FDA.
Responding to FDA Inspections Inadequately
How you handle FDA inspections affects both the immediate inspection outcome and your longer-term compliance status. Common mistakes during inspections create unnecessary compliance problems.
Failing to Provide Requested Records Promptly
FDA investigators have authority to review records relevant to inspection scope. Delays in producing records or claims that records don’t exist create red flags for investigators.
If you can’t produce requested records immediately, explain when you can provide them and why there’s a delay. Don’t make investigators wonder whether you’re hiding information or don’t maintain required records.
Making Unsubstantiated Statements to Investigators
Statements you make during inspections become part of the inspection record. Making claims about your procedures, controls, or compliance without supporting documentation creates problems when records don’t support your statements.
If an investigator asks whether you conduct specific verification activities, answering “yes” when you can’t produce records of those activities suggests you either don’t actually conduct the activities or don’t document them properly. Either scenario represents a compliance failure.
Not Having Knowledgeable Staff Available
Investigators need to interview people who actually understand your operations. Having only administrative staff available who can’t answer technical questions about your food safety systems signals to FDA that your management doesn’t prioritize compliance.
Your quality assurance manager, production supervisors, and PCQI should be available during inspections to answer questions about their areas of responsibility. If key personnel aren’t available, explain why and when they can meet with investigators.
When FDA Compliance Mistakes Require Legal Counsel
Most routine compliance activities can be managed internally by your quality and regulatory teams. But certain FDA compliance situations benefit from specialized legal counsel that understands agency processes and can protect your interests.
Receiving Warning Letters
FDA warning letters represent formal agency positions that your facility is violating regulations. How you respond to warning letters determines whether FDA considers the violations resolved or escalates enforcement.
Warning letter responses create legal records that FDA will evaluate in any subsequent enforcement proceeding. Your response should address each cited violation with specific corrective actions, but framing matters significantly.
Legal counsel helps you craft responses that satisfy FDA expectations while preserving your defenses if the agency escalates enforcement. In-house teams without regulatory law experience may inadvertently make admissions that create broader liability or fail to raise relevant legal arguments that could narrow the scope of violations.
I’ve seen companies provide overly detailed corrective action plans that commit them to changes beyond what regulations require, or acknowledge violations without reserving the right to contest characterizations. Warning letter responses require balancing FDA’s expectations with your legal interests – something specialized counsel manages effectively.
Facing Import Detention or Refusal
When FDA detains or refuses your imports, you face immediate business disruption and need to respond within specific timeframes. These situations require understanding both FDA import regulations and Customs procedures.
You have limited time to respond with evidence that your products meet requirements or to request reconditioning. Legal counsel familiar with FDA import procedures can evaluate your response options, represent you in communications with FDA, and help you implement corrective actions that prevent future detentions.
Import alerts create ongoing compliance problems by automatically flagging your products for detention. Getting removed from import alerts requires demonstrating comprehensive corrective actions that address underlying compliance problems.
Responding to Requests for Recalls
When FDA requests voluntary recalls, you face decisions that affect product liability, regulatory compliance, and business relationships. How you manage recalls requires coordination across legal, regulatory, and business functions.
Recall decisions include determining scope, classification, public notification approach, and communication strategy. Each decision has legal implications that extend beyond regulatory compliance. Your recall communications become evidence in potential litigation. How you characterize product problems affects your legal position with customers, consumers, and insurers.
Legal counsel helps you manage recalls to satisfy FDA requirements while protecting against broader liability exposure. This includes crafting recall notifications, coordinating with FDA on effectiveness checks, and managing communications that don’t create unnecessary legal exposure.
Dealing with Subpoenas or Criminal Investigations
FDA Office of Criminal Investigations handles cases involving intentional violations. If you receive document subpoenas, interview requests from OCI agents, or grand jury subpoenas related to your products, you need immediate legal representation.
Criminal investigations can result in prosecution of company officials for violations of federal food and drug laws. Making statements to investigators without counsel can create admissions that support prosecution. Providing documents without understanding what investigators are seeking can inadvertently supply evidence of violations.
Legal counsel experienced with FDA criminal matters protects your rights during investigations, ensures you comply with legitimate requests without waiving privileges, and helps you understand the scope and seriousness of the investigation.
Addressing Repeat Observations or Consent Decrees
When warning letters don’t resolve compliance problems, FDA can seek consent decrees that place your facility under court supervision. These situations require legal representation to negotiate consent decree terms and manage compliance under court-enforced requirements.
Consent decrees typically require third-party audits, FDA access to facilities, and financial penalties for non-compliance. The terms of consent decrees are negotiated with FDA and Department of Justice attorneys. Having experienced regulatory counsel during these negotiations protects your interests and creates workable compliance obligations.
Building Systems That Prevent FDA Compliance Mistakes
Preventing FDA compliance mistakes requires structured systems rather than reactive problem-solving. Companies that maintain strong FDA compliance share common characteristics in how they approach regulatory obligations.
Establishing Clear Quality System Ownership
Someone in your organization must own compliance – not just manage day-to-day quality activities but actually ensure your systems meet current regulatory expectations.
This person needs authority to halt production when compliance problems arise, access to executive leadership to secure resources for compliance improvements, and accountability for maintaining current knowledge of FDA requirements.
Implementing Regular Gap Assessments
Regulations evolve and FDA enforcement priorities shift. Regular internal assessments identify compliance gaps before FDA inspections reveal them.
Third-party audits by consultants familiar with FDA expectations provide objective evaluation of your compliance status. These audits should evaluate not just whether you have required programs but whether those programs actually meet current industry standards.
Maintaining Robust Training Programs
Your employees implement your quality systems. Inadequate training shows up through documentation failures, procedural deviations, and investigation gaps.
Training should be specific to job functions, documented with records showing who received training and when, and updated when procedures change or FDA guidance evolves. Generic food safety training doesn’t substitute for job-specific instruction in your actual procedures.
Monitoring FDA Enforcement Trends
FDA publishes warning letters, import refusals, recall notifications, and enforcement reports. These publications show where FDA is focusing attention and how the agency interprets regulations.
Companies that monitor enforcement trends identify emerging compliance issues before they become industry-wide problems. If FDA is issuing multiple warning letters about specific violations, you should evaluate whether your facility has similar vulnerabilities.
Take Control of Your FDA Compliance
FDA compliance mistakes happen even at well-managed facilities, but understanding common errors helps you prevent them through structured quality systems. The mistakes outlined here – from CGMP inadequacies to preventive controls failures to labeling violations – appear repeatedly across FDA enforcement actions because companies don’t recognize where their compliance approaches fall short of current agency expectations.
Success requires treating FDA compliance as continuous improvement rather than static compliance with fixed standards. Your procedures must reflect current industry practices. Your documentation must demonstrate you’re actually following those procedures. Your quality systems must identify and address problems before FDA inspections reveal them.
Know when your internal resources are sufficient and when specialized legal counsel adds value. Routine compliance can be managed internally, but warning letters, import detentions, recalls, and criminal investigations all benefit from experienced regulatory attorneys who understand FDA processes and can protect your interests while resolving compliance issues.
If you’re facing FDA enforcement actions, need guidance responding to warning letters, want to evaluate your compliance systems, or require legal representation during FDA investigations, OFW Law provides specialized counsel for food and dietary supplement manufacturers navigating FDA requirements. Contact our team to discuss how we can support your compliance needs and help you prevent or resolve FDA compliance mistakes before they escalate into serious enforcement consequences.
