I Don’t Want Your Photograph: Actually, FDA Might Want to Take Photographs During an Inspection

While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs during an FDA inspection.¹ We have written in the past about companies’ refusal to allow, or make difficult, an FDA investigator’s ability to access certain records or files during an inspection.² It is not only a bad idea, but it is also a prohibited act.³ However, one does not often read in a Warning Letter about FDA raising “limiting photography” as part of restricting FDA access.⁴ Well, here we go.

The Warning Letter stemmed from an inspection of a drug manufacturing facility located outside of the United States. Most of the Warning Letter focused on quality-related deficiencies. However, the agency’s discussion about inspectional access is equally, if not more, instructive for FDA-regulated industry.

Highlights

• FDA requested certain process validation information for the firm’s over-the-counter drug product and a manufacturing production batch record.
• The company translated the documents line by line but “were unreasonably redacted.”
  • The letter notes, “Your firm’s actions during this inspection significantly hindered FDA from fully assessing your compliance with CGMP [Current Good Manufacturing Practices]. When our inspection team explained that our failure to provide the requested records would be documented as a refusal, you acknowledged the refusal.”
• The company provided some, but not all, of the FDA-requested corrective actions and preventive actions.
• Separate from the documentation request, the agency noted the “limiting photography” violation toward the beginning of the Warning Letter.
• Specifically, FDA tried to take photographs of filling machines, which were, in the agency’s description, “dirty and in an apparent state of disrepair, despite the equipment status being identified as clean.”
• Management stated that the investigators were not allowed to take photographs of the equipment.
• FDA informed the company that its failure to allow photography would be documented as a refusal. Again, the firm acknowledged.

Background on Inspectional Authority and Taking Photographs

• The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) does not explicitly require companies to permit photographs to be taken. Section 704 of the FD&C Act requires FDA-regulated industry to allow FDA investigators to “inspect, at reasonable times and within reasonable limits and in a reasonable manner,” any facility and “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.”⁵
• FDA has always claimed that it may take photographs while conducting an inspection, as described in its Investigations Operations Manual (at Section 5.6.7.1): “photos are an integral part of an inspection.” The manual also advises inspectors that, if the company refuses photographs, to cite two court cases that the manual claims authorize the taking of photographs. However, it is important to note that those cases only authorized use of photographs in court when the investigated firm did not refuse to permit photographs to be taken (and, therefore, could be used against the company) or to photos taken by other regulatory bodies in different contexts (e.g., the Environmental Protection Agency and aerial photographs).⁶
• The FDA Safety and Innovation Act (“FDASIA”), enacted in 2012, added section 501(j) to the FD&C Act, which states that a drug that “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” is adulterated.⁷
• FDASIA also required FDA to issue guidance that described situations that could constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).
• FDA finalized a guidance document in June 2024, “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.”⁸
• The guidance notes “limiting photography” may improperly limit an FDA inspection, which could cause FDA to determine that the products at that facility are adulterated.
  • Examples of conditions or practices FDA identifies as being effectively documented by photographs include:
    • evidence of rodents or insect infestation;
    • faulty construction or maintenance of equipment or facilities;
    • product storage conditions;
    • product labels and labeling; and
    • visible contamination of components, containers, closures, or products.

AGG Observations

• FDA is trying to make a point about its inspectional authority, and photographs, following the issuance of the June 2024 guidance document.
• All inspections are specific and it is possible that, in this case, the company’s lack of cooperation antagonized the investigators and led to the photography request (or the clear appearance of dirt needed to be captured). It is not our experience that FDA inspectors typically seek to take pictures.
• The Warning Letter did not suggest that the company had a policy about prohibiting photography. It is a good idea to have such a policy. While a policy might not necessarily stop FDA from taking photos, it shows that the company knows its rights and is vigilant (and puts other visitors to the company on notice about the ban on photography).⁹
• It is useful to ask the FDA inspector why there is a need to take pictures (maybe the company can respond to an inquiry without the photo).
• If the company allows FDA to take photographs, it should then take side-by-side pictures, so it knows what FDA is taking and can respond accordingly.

Bringing it back to the Def Leppard lyrics, even if you don’t want a photograph, be prepared that FDA may want to take some photographs of your facility during an inspection.

[1] The Warning Letter can be accessed here.

[2] See past AGG bulletins: There’s No Reply At All: It’s Never a Good Idea To Ignore FDA During an Inspection (and, in Fact, It’s Illegal); Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection.

[3] 21 U.S.C. § 331(e)-(f).

[4] In August 2017, Homeolab USA received a similar Warning Letter observation, although it was the last substantive observation in the letter (as compared to the Warning Letter here, where the allegation ranked near the top). The 2017 Warning Letter can be accessed here.

[5] 21 U.S.C. § 374(a)(1).

[6] Dow Chemical Co. v. United States, 476 U.S. 227 (1986) and United States v. Acri Wholesale Grocery Co. 409 F. Supp. 529 (S.D. Iowa 1976).

[7] 21 U.S.C. § 351(j). The FDA Reauthorization Act, enacted in 2017, amended the scope of section 501(j) to include medical devices.

[8] The guidance document can be accessed here. This guidance finalizes the draft guidance of the same title issued on December 16, 2022, and supersedes the October 2014 guidance, “Circumstances that Constitute Delaying, Limiting, or Refusing a Drug Inspection.”

[9] Companies may have commercial reasons to prohibit third parties from taking photographs, such as protection of intellectual property.