In finalizing a policy aimed at ensuring companies aren’t able to hide problems during inspections, the agency provided the industry with additional details regarding facility inspections in a bid to reduce confusion, adding descriptive material and preserving robust rules about photography.
In 2013, the FDA issued a draft guidance document, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” in an attempt to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act, under which drugs can be considered adulterated due to “circumstances that constitute delaying, denying, limiting or refusing a drug inspection.” That provision has since led to numerous FDA warning letters to manufacturers.
Before the rule passed, some firms sought to refuse or delay entry of FDA inspectors into their facility in a bid to use the additional time to clean up or expunge certain records. The 2013 guidance served as the industry’s first look at how the FDA would interpret and put into practice legislators’ authority.
Of the draft’s sections, the one on photography was likely the one to garner the most attention, and the final version is meaningfully similar to the language in the draft guidance. Some companies contended the provision could threaten their IP rights, and other legal experts questioned whether the photography provision might stand up to legal scrutiny if challenged in court. While some urged the FDA to offer flexibility in regard to inspectors’ unequivocal authorization to take photographs, the final guidance actually eliminated possible loopholes.
The FDA did, however, clarify that companies can object to the photographing of an area in the event that the photograph would "adversely affect product quality."
The final guidance also addresses a main point of uncertainty in the draft version by adding material describing “reasonable explanations” for delays, denials and limitations, and eliminating the words “adequate justification.”