FDA Compliance
Warning letter responses, Form 483 observations, 503A compounding oversight, and advertising review for Tennessee community and compounding pharmacies, from a former state regulator with a litigation firm behind him.
Eleven years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health.
Licensed in Tennessee, with federal practice before the DEA, FDA, and HHS nationwide.
The healthcare division of Litson PLLC, ready if a matter reaches court.
How we approach it
An FDA warning letter or a Form 483 with a list of observations reads as a verdict, but it is closer to a detailed set of questions about how a pharmacy operates, and the agency is waiting to see how seriously those questions are taken. Matt Gibbs spent more than eleven years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health, where compounding oversight and the state-federal handoff were part of the daily work, so he reads an FDA observation with a clear sense of what the investigator saw and what the reviewer expects to hear back. The deadline is short, usually 15 business days, and the response carries more weight with the agency than most pharmacies realize when the letter first arrives.
The response is built observation by observation. Investigators are thorough, and the observations they write are usually accurate as far as they go, so the work is explaining the context, documenting the corrective actions already taken, and laying out a realistic plan with dates for the ones still in progress, in the format the agency is used to relying on. A response that is specific, honest about what happened, and credible about what changes next is the one that closes the matter, and it is the same response that protects the pharmacy if the agency follows up months later to confirm that what was promised was done.
Much of this practice is preparation rather than response. Sterile and non-sterile compounding under 503A, product sourcing, and the way a pharmacy describes what it makes on its website and in its marketing all draw attention, and compounded GLP-1 products in particular have brought manufacturer scrutiny and lawsuits to pharmacies that never expected them. Reviewing those pieces before an inspection or a demand letter arrives is how a pharmacy stays off the radar in the first place, and when a matter does escalate, the litigation firm behind RxLaw Group is already familiar with the file and ready for whatever form the matter takes.
What we handle
From the observation list to the closeout letter, and the preparation that keeps the list short.
A complete, observation-by-observation response with corrective actions, documentation, and a credible timeline, inside the agency’s deadline.
Responding to inspectional observations promptly and thoroughly, which is often what keeps a 483 from becoming a warning letter.
Preparing the pharmacy and its staff before an inspection, and standing with you during one so the record is accurate and complete.
Reviewing sterile and non-sterile compounding practices, sourcing, and documentation against what the agency and the Board expect.
Reviewing product claims, especially for compounded GLP-1 and other products that draw manufacturer and agency attention.
Handling agency follow-up, corrective action plans, and the matters that escalate, with Litson PLLC’s litigators behind the response.
An active warning letter, 483 response, or enforcement matter is handled on an hourly or retainer basis with a clear scope and estimate before work begins. Members get the preparation that keeps the observation list short: unlimited questions, compounding and advertising review, and inspection readiness on one flat monthly fee.
Common questions
A warning letter typically asks for a written response within 15 business days of receipt, and the letter itself will state the deadline that applies to you. That window is enough to prepare a thorough response if the work starts right away, which is why the first step is to read every observation closely and begin gathering the records and corrective actions that answer each one.
A Form 483 is the list of observations an investigator leaves at the end of an inspection, and it reflects conditions the investigator believes may violate the law. A warning letter comes later, from the agency rather than the investigator, once the observations and any response have been reviewed. A prompt, specific response to the 483 is often what keeps a warning letter from being issued at all.
Membership covers the questions, compounding and advertising review, and inspection preparation that surround an FDA matter, and it is the reason most members never receive one. An active warning letter response, 483 response, or enforcement action is a separate engagement, scoped and estimated up front on an hourly or retainer basis, so there is never a surprise about what is covered.
Drug manufacturers have been sending demand letters and filing lawsuits over how pharmacies and clinics advertise compounded semaglutide and similar products, and the FDA pays close attention to the same claims. The trouble is rarely the compounding itself and more often the way a product is described, so reviewing your website and marketing before anyone else does is one of the most valuable things a compounding pharmacy can do right now.
Talk to Matt
15 minutes with Matt Gibbs. Skip the long intake form and get a straight answer on whether we can help.
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