“Attention to detail is key when it comes to regulatory compliance. I research my clients’ needs with the same level of rigor and scrutiny as I would my own.”
- Washington, DC
- abartosch@ofwlaw.com
- 202-518-6312
April Bartosch routinely aids clients with matters related to FDA and USDA compliance. Years of experience in the field and a thorough understanding of the relevant regulations enable April to effectively assist companies with a variety of matters, ranging from premarket product development to post-market enforcement action.
FDA Regulatory Compliance
April specializes in compliance with FDA labeling regulations, particularly with respect to food and dietary supplement products. She assists clients with other aspects of FDA compliance as well, including:
- Reviewing product claims to ensure conformance with the applicable marketing category.
- Resolving detentions through means such as communicating with Compliance Officers on clients’ behalf; drafting and submitting a Form 766 Request to Recondition; and arranging for third-party laboratory testing of product, as applicable.
- Petitioning FDA to remove firms from import alert.
- Applying for inclusion on an FDA Export List.
- Fulfilling applicable registration and listing requirements.
USDA Regulatory Compliance
April has extensive proficiency with respect to USDA compliance. Her experience in this area includes:
- Ascertaining the need for an import permit on animal-containing materials and plant-containing materials.
- Applying for Veterinary Services (VS) permits and PPQ (Plant Protection and Quarantine) permits from USDA Animal and Plant Health Inspection Service (APHIS).
- Submitting on-hold shipment notifications to USDA on behalf of clients with detained entries and successfully obtaining their release.
- Ensuring compliance with the USDA Food Safety and Inspection Service (FSIS).
- Confirming proper use of the “organic” designation.
- Obtaining health certificates, sanitary certificates, and export certificates from USDA’s Agricultural Marketing Service (AMS) and APHIS.
General Regulatory Compliance
April’s compliance background includes experience with a number of entities in addition to FDA and USDA. She has assisted businesses with the incorporation process as well as with compliance with state-level regulations in areas ranging from product registration to facility licensing. Her expertise includes obtaining Certificates of Free Sale and apostilles from the relevant issuing agencies. She is a certified Preventive Controls Qualified Individual (PCQI).
Practice Areas
Past Experience
- Regulatory Specialist focusing specifically on label compliance for food, dietary supplements, cosmetics, and drug products.
Credentials
Education
College of William and Mary – B.A., Linguistics, Hispanic Studies (2013) PCQI Certified (2021)
Leadership and Community
As a longtime migraine sufferer herself, April is an advocate for migraine research and management. Since October 2020, she has volunteered as a member of the content editing team of the Migraine World Summit. April is also an active member of the Patawomeck Indian Tribe of Virginia.
News & Insights
May 21st, 2018
January 24th, 2018
September 19th, 2017