Applying the Drug Guidance "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" to Food Operations

FDA recently issued a guidance for drug related companies titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection". Some have suggested that this type of guidance may be extended to food processing facilities that fall under FDA jurisdiction.

It is stated in this guidance:

It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or inspection or refuse to permit access to or copying of certain specified records.10 New section 501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated if "…it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection."

 Basically, if they can't see what they want, when they want, that product is adulterated.

The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.

It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf