“You come to us because the issue is unique. I bring the experience and imagination to reach the resolution and your success.”
David L. Durkin
Principal
- Washington, DC
- ddurkin@ofwlaw.com
- (202) 518-6313
Mr. Durkin specializes in food safety regulation by the FDA with more than twenty-five years’ experience working directly with the produce industry. He has led the firm’s practice in Drug Enforcement Administration issues and works before both the Animal and Plant Health Inspection Service and the Agricultural Marketing Service, among other USDA agencies.
FDA Litigation & Compliance
- Regulated product applications and approvals
- Section 510(k) applications for medical devices
International Trade
- Import issues involving FDA and USDA regulated products, including import alerts, holds, detentions, and refusals
- Customs and Border Protection petitions regarding liquidated damages
Food Safety
- Management of food recalls
- Counsel and assistance with regular and post-recall inspection issues
- Review of food safety and crisis management planning
- Import Alerts, product detentions, refusals, and reconditioning
Drug Enforcement Administration
- Advise DEA registrants regarding compliance issues, including suspicious order monitoring systems
- Assist with obtaining DEA registrations
Practice Areas
- National Organic Program
- Cannabis
- PACA
- Trade Associations
- Enforcement & Litigation
- Inspections
- Food Recalls
- Food Labeling & Advertisement
- Food Service, Restaurants & Retailers
- Trade Remedies and ITC Investigations
- Customs & Import/Export Regulations
- Checkoff Programs
- FDA Food Law and Food Safety
- Facility Registrations
- Due Diligence
- Lobbying & Public Policy
- Farm Bill
- Political Action Committees
- Coalition Building
- Native American Issues
- Pharmaceuticals & Biologics
Past Experience
- Develop product safety compliance programs
- Product review for regulatory compliance and product liability risk mitigation
- Due diligence review in consumer product corporate acquisitions
- Corrective action plans, including recalls
