FDA Law Blog Provides Their Take on the FDA Guidance Regarding Inspections, but Remember They Are Lawyers Making the Arguments To Represent One Side in the Equation: The FDA Guidance is Not Written for the Parties Being Inspected--the Guidance is for the FDA and its employees.

This guidance does give clues to those being inspected as to arguments the FDA is willing to make in court and as to arguments it thinks it has a "reasonable" chance of prevailing on if it goes to court.  In the compounding area, one has to look no further than the Congressional hearings on the NECC outbreak and how some compounding pharmacies refused to allow the FDA to inspect and how some organizations that represented them advised them to refuse to be inspected.  We all know how those played out in court so we do know the FDA has prevailed in the past.   Even if it hadn't, these refusal showed examples of where the FDA tried to get a handle on compounders who were possibly manufacturing but roadblocks were put up by the compounders,  which eventually was used to convince Congress to pass the DQSA.  The lawyers writing the FDA Law Blog do point out that each company/place/business should have its own internal procedures for an FDA inspection and that one should consult an attorney for guidance on these internal procedures.

The FDA Law Blog's take on this guidance can be read at

October 22, 2014

What Can FDA Do During Drug Inspections: Will FDA Apply Its New Guidance to Other Products?

By Jay W. Cormier & Anne K. Walsh –