Anatomy of an FDA inspection
On April 25th I attended my first FDA (U.S. Food and Drug Administration) Medical Device Establishment Inspection.
Agent (Investigator) Kimberley A. Ricketts called me a couple days before to let me know that as a registered medical device manufacturing company, Kanteron Systems (the company I founded in 2005) had been selected for an Establishment Inspection. It was the “Notice of Inspection pursuant to Section 704(a)(1) of the Federal Food, Drug, and Cosmetics Act [21 U.S.C. 374(a)] and Part F or G, Title III of the Public Health Service Act [42 U.S.C. 262-264]".
The first thing that impresses, scares and confuses anyone dealing with the FDA is the amount of codes, regulations, and procedures. In this case, this Level 1 inspection was conducted as part of the NYK-DO Work Plan under FACTS ID#1456352 in accordance with Compliance Program 7382.845. Luckily it was finished May 13th without the issuing of any FDA-483, so they “closed it” (the inspection) under 21 C.F.R. part 20.64 (d) (3) and wrote an EIR in accordance to the FOIA and 21 C.F.R. part 20.
The second thing that impresses (at least it was something I was not expecting, and apparently something that causes much confusion) was to open the door and see the Investigator, as part of the United States Public Health Service Commissioned Corps (PHSCC), I guess, dressed in a military uniform derived from the Navy uniforms, and with a badge. At least she was not a Special Agent carrying a gun!
So the very nice Mrs. Ricketts started by showing me her ID and badge, and handing me an FDA Form 482 (9/11) which listed all the applicable portions of Section 704 and other Sections of the Federal Food, Drug, and Cosmetics Act [21 U.S.C. 374]. Looooong list.
The we spent the next two days (actually, April 25th was the first, but due to personal matters, she could not do the inspection`s second session until May 13th) going over all kinds of documentation: quality management system, customer communications, installations, development processes, feedback, auditing, security, bugs, reports… a lot, I mean A LOT, of documentation was reviewed.
It is a reassuring pleasure to receive the final report stating that everything is correct. But it is not a fun experience, that`s for sure.