No Room for Camera Shyness: FDA Issues Another Warning Letter Citing Refusal to Permit PhotographyAugust 16, 2017
FDA seems to be getting bolder in penalizing industry when it prevents an FDA investigator from taking photographs during a routine FDA inspection.
On August 2, 2017, FDA issued a Warning Letter to Homeolab USA Inc. (part of the parent company, Homeocan Inc. located in Montreal, Québec) for, among other things, impeding the FDA inspection by preventing the investigator from photographing a piece of equipment. FDA claimed the alleged failure to permit photographs constitutes a violation of the Federal Food, Drug, and Cosmetic Act (FDC Act), citing section 501(j) of the FDC Act, which deems drugs adulterated when an owner or operator of a drug facility limits an FDA inspection. FDA relied on its Guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection”, which provides examples of behavior that FDA considers to constitute a limitation and explicitly states that “impeding or resisting photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator to be necessary to effectively conduct that particular inspection.” Based on this and other alleged violations, FDA asserts in the Warning Letter that drugs produced at the Homeolab USA facility are deemed adulterated because of the company’s refusal to allow photographs.
Also, because Homeolab USA’s parent company is located in Québec, FDA banned the company’s products from entering the United States by placing the company on Import Alert 66-40. The Import Alert means that FDA can detain, without physical examination, products imported to the United States, and can continue to detain these products until it is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center.
FDA previously issued a citation relating to a photo refusal in a September 2016 Warning Letter to Nippon Fine Chemical Co., Ltd. (see our previous post here). This Warning Letter was of note because FDA effectively shut down a drug facility based solely on its conduct during an FDA inspection. FDA deemed the drugs produced at the facility adulterated based on the fact that the company limited an inspection and/or refused to permit the FDA inspection in three ways: 1) barring access to areas, 2) refusing to provide copies of documents, and 3) limiting photography. That Warning Letter cited no other observed GMP or safety concern related to the company’s products or procedures.
The recent increase in Warning Letters referencing limiting photography as a violative act shows that FDA, relying on its non-binding guidance, is employing an expansive approach in exercising its inspection powers. This is in spite of the fact that, as far as we know, there has been no case in which a court has held that a company’s refusal to allow FDA inspectors to take photographs constitutes a violation of the FDC Act (see previous posts here and here).
But we will be watching closely to see whether a court agrees that FDA’s inspection authority requires industry to permit investigators to take photographs during routine inspections, and will ensure that our faithful blog consumers are made aware of developments.
* Not admitted in the District of Columbia