|Footnotes for this article are available at the end of this page.
Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here).1 Rule Number Two: Assuming Rule Number One applies, the facility cannot deny FDA access to those records and information to which it is entitled. In fact, it is a prohibited act.2 Recently, FDA issued a Warning Letter to a manufacturer of over-the-counter drug products (including hand sanitizers) reminding industry of Rules One and Two.3 Reading the Warning Letter reminded the author of the 1981 classic rock song by Genesis, “No Reply At All.”
In the Warning Letter, the agency wrote that it attempted to contact the company by email and by telephone several times, but to no avail. It sent a follow-up written request for written records by certified return-receipt mail. Again, no response. Because the company did not respond, FDA found that it refused the agency access to inspect, which is a prohibited act. FDA directed the company to confirm or update its registration and/or drug listing status and said that if the company was not manufacturing the products, it should delist them.
Bottom Line: remember Rules One and Two and, to take another song from the Genesis catalogue, make sure there is no misunderstanding and reply to FDA.
A partner and leader of the Food & Drug team, Alan Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the U.S. Food and Drug Administration. AGG attorney and former acting Director and Deputy of the Office of Dietary Supplement Programs (ODSP) Robert Durkin brings policy analysis and evaluations related to all aspects of dietary supplement programs while providing advice on compliance and enforcement issues.
 21 U.S.C. § 374.
 21 U.S.C. § 331(e).