Who We Represent in FDA Matters
- Peptide and research-use-only (RUO) vendors
- 503A compounding pharmacies and 503B outsourcing facilities
- Med spas, IV therapy clinics, and weight-loss clinics
- Telehealth platforms prescribing GLP-1 and peptide therapies
- Supplement, wellness, and longevity brands
- Importers, distributors, and fulfillment partners
- Owners, officers, pharmacists-in-charge, and medical directors personally named or exposed
How an FDA Matter Escalates
| Stage | What it is | What it signals |
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| Inspection and Form 483 | Written observations handed over at the close of an inspection | FDA found conditions it believes may violate the law. Your response is due in 15 business days. |
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| Untitled letter | Notice of violations below the warning letter threshold | FDA is watching; a written response is expected. |
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| Warning letter | Formal notice of significant violations, published online | FDA expects prompt correction and will verify it. Response due in 15 working days. |
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| Regulatory meeting or reinspection | FDA tests whether promised corrections were made | Broken promises here drive the next step. |
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| Import alert, seizure, or injunction | Detention of product at the border, court seizure, or a consent decree | The business itself is at risk. |
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| Criminal referral | FDA's Office of Criminal Investigations works with DOJ | Owners and managers face personal exposure under 21 U.S.C. § 333. |
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Why Your Response Is a Legal Document, Not a Compliance Memo
Most 483 and warning letter responses are written by consultants focused on fixing the facility. That work matters, but the response is also a written statement by the company to a federal agency. It can concede facts that prove a violation, promise corrections the company cannot deliver, or describe a practice in words that read as intent.
The Federal Food, Drug, and Cosmetic Act allows prosecution of company officers for violations they had the authority to prevent, without proof they intended the violation (21 U.S.C. § 333(a)(1); United States v. Park, 421 U.S. 658 (1975)). Violations committed with intent to defraud or mislead are felonies (21 U.S.C. § 333(a)(2)). Conduct can also be charged as conspiracy, wire fraud, or money laundering, which carry far heavier penalties. A response written with that exposure in mind protects the business and the people who run it.
What a Strong Response Includes
- A direct answer to every observation or cited violation, in order
- An investigation into the root cause, not only the symptom
- Corrective and preventive actions with owners and completion dates
- Evidence: revised procedures, training records, test results, photographs
- Commitments the company can keep, and a schedule for update reports
- A request for confidential treatment of trade secret and commercial information
- Signature by an executive with authority, reviewed by counsel before it is sent
FDA's March 2026 draft guidance on responding to drug manufacturing 483s describes the same elements and states that a response may be the primary or a key component of the agency's decision on further action. We treat that guidance as the benchmark for every regulated client.
Where Peptide, Compounding and Med Spa Businesses Get Cited
- Research-use-only labeling paired with human-use marketing. Dosing guides, before-and-after content, or influencer claims turn an RUO product into an unapproved drug in FDA's view.
- Unapproved new drug and misbranding theories. Products marketed for treatment without FDA approval, or without adequate directions for use (21 U.S.C. §§ 331, 352, 355).
- Compounding outside the statutory lanes. Bulk substances that are not eligible for compounding, including peptides FDA has placed in Category 2 of its interim bulk substance list, and 503A compounding without patient-specific prescriptions (21 U.S.C. §§ 353a, 353b).
- GLP-1 copies after the shortages ended. FDA declared the tirzepatide and semaglutide shortages resolved in December 2024 and February 2025. Compounding copies of commercially available drugs is restricted.
- Sterile compounding and facility conditions. Adulteration based on insanitary conditions (21 U.S.C. § 351).
FDA Is Rarely the Only Agency
In Florida, the Department of Health and the Board of Pharmacy enforce the Florida Pharmacy Act (Chapter 465) and the Florida Drug and Cosmetic Act (Chapter 499), and professional licenses are at stake for pharmacists, physicians, and nurses. State attorneys general, other states' pharmacy boards, payment processors, and drug manufacturers enforcing their patents and trademarks can all act on the same facts. We coordinate the FDA response with each of them so that what you tell one agency does not hurt you with another.
How AMC Defense Law Helps
- Review the 483 or letter and assess criminal and licensing exposure before anything is sent
- Direct regulatory and quality consultants through counsel, to protect privilege where the law allows
- Draft or edit the response and the follow-up reports
- Handle regulatory meetings and communications with FDA
- Review websites, product pages, and social media for the claims regulators cite first, and flag what needs to change
- Take over if FDA criminal investigators, a grand jury subpoena, or a search warrant follows
