You Received an FDA Warning Letter. Here’s What to Do Next.
An FDA warning letter is one of the most serious enforcement actions the agency can take short of a seizure or injunction. It signals that the FDA has identified a significant violation — in your labeling, manufacturing practices, product claims, or facility operations — and expects a written response within 15 business days.
Do not ignore it. Do not respond without legal counsel. A poorly written or incomplete response can escalate a correctable situation into an extended enforcement action, import alert, or consent decree.
Capote Law Firm has helped dietary supplement, cosmetics, food, and medical device companies respond to FDA warning letters and resolve enforcement actions since 2006. Schedule a free consultation today.
What Is an FDA Warning Letter?
An FDA warning letter is an official communication from the FDA notifying a company that it has violated federal law — typically the Federal Food, Drug, and Cosmetic Act (FD&C Act). Warning letters are publicly posted on the FDA’s website and searchable by company name.
Common reasons FDA issues warning letters to our clients’ industries:
- Dietary supplements: Unapproved drug claims, cGMP violations, undeclared ingredients, or failure to report serious adverse events
- Cosmetics: Drug claims on cosmetic products, MoCRA non-compliance, prohibited ingredients, misleading labeling
- Food: FSMA violations, foreign supplier verification failures, undeclared allergens, misbranding
- Medical devices: 510(k) submission failures, inadequate quality system regulations, unauthorized marketing claims
- OTC drugs: Violations of OTC monograph requirements, labeling deficiencies, cGMP failures
The 15-Business-Day Response Deadline
The FDA expects a written response within 15 business days of receiving a warning letter. Failure to respond promptly almost always results in escalated enforcement, including placement on Import Alert, product seizure, injunction proceedings, or referral to the FDA’s Office of Criminal Investigations.
What a Strong Warning Letter Response Includes
- A specific response to each violation cited in the warning letter
- Immediate corrective actions already taken
- A timeline and plan of action for full remediation
- Procedures implemented to prevent recurrence
- Documentation and evidence supporting each corrective action
How Capote Law Firm Helps
- Immediate review: We analyze the warning letter in full, identifying every cited violation and its regulatory basis.
- Triage: We separate immediate actions from longer-term corrective actions.
- Response drafting: We prepare a written response addressing each observation with supporting documentation and a corrective action timeline.
- Ongoing compliance: We help you implement the corrective action plan and prepare for any follow-up FDA inspection.
Frequently Asked Questions
How quickly do I need to respond to an FDA warning letter?
The FDA asks for a response within 15 business days of receipt. Contact Capote Law Firm immediately so we can begin preparing your response.
Can I respond to an FDA warning letter myself?
Technically yes, but it is not advisable. FDA warning letters cite specific regulatory provisions, and your response needs to address each one with precision. An incomplete or misdirected response often makes the situation worse.
Does Capote Law Firm handle warning letters for companies outside Miami?
Yes. We advise clients nationwide and internationally. FDA warning letters are federal matters — location does not limit our ability to represent you.
Ready to respond? Call (786) 207-1174 or schedule a free consultation. Available Monday–Friday, 9 AM–5 PM.