By EAS Senior Consultant Joseph Famiglietti
Managing an FDA inspection is in itself a difficult task, but what should you do when an FDA investigator wants to take photographs at your facility? Whether it is pest sightings, equipment issues, or poor employee practices, the investigator has been trained by FDA to document situations such as these with photographs which can be used as evidence in a legal action.
If you do not permit photography, it is FDA policy to list this action in the inspection report as a “Refusal.” A photography refusal may be used against a company in a future legal proceeding to demonstrate a firm’s uncooperative regulatory attitude.
Your company should have written procedures covering the use of cameras in your facility by visitors, including FDA. The FDA believes they have the right to take photographs. Their procedures direct investigators to take inspectional photographs as deemed necessary without asking for permission to do so. Guidance is also provided to inspectors on how to handle photography refusals including obtaining the contact information for the firm’s attorney or other responsible individual so FDA management can discuss the refusal with them. The current FDA procedures regarding use of the camera are discussed in the IOM, Section 5.3.4.1 (http://www.fda.gov/ICECI/Inspections/IOM/default.htm). If refused, FDA may elect to obtain a warrant to take the desired photographs.
Your company may not want to allow FDA to use a camera in your facility for a number of reasons, including protection of trade secrets or concerns that the photographs may not accurately depict the conditions. Refusing to allow FDA to take photographs can cause delays in the completion of the inspection. The agency could consider this as a partial refusal of inspection and it may be viewed as a prohibited act possibly resulting in a regulatory action.
FDA published a guidance document discussing photography refusals at drug establishments as a behavior that could cause limiting of the inspection, which may result in an adulterated drug charge. The document, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” can be viewed at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf.
Although FDA has not published similar guidance regarding photography refusals in other FDA inspected facilities such as food firms, the agency would consider a test case to establish a court ruling on this matter.
At the onset of an inspection, the investigator will probably be carrying a camera as part of FDA issued inspectional equipment. If your company is in compliance, it is likely there will be no need for photographs. With concurrence from your legal advisor, perhaps you should consider having a respectful discussion with the investigator prior to the start of the inspection explaining your company policies and concerns. If your primary concern is protection of trade secrets, perhaps the investigator will be sensitive to your needs and exercise discretion when using the camera.
If an FDA inspector does take photographs, you should always take the same pictures for your own records. Rather than outright refusing any regulatory photography at your facility, you might request to take all photographs under FDA supervision with the agency getting all original discs or film. However, investigators prefer to take their own pictures and they would probably have to obtain supervisory permission to use your photographs.
In some instances, FDA might agree to allow industry participation in taking the pictures, if the agency prefers not to obtain a warrant. FDA considers each situation on a case by case basis and you might be surprised as to what you can get by having an open and honest dialog with the agency. Although the legal issues need to be resolved regarding FDA’s authority for camera use, it would be helpful to negotiate with the agency and perhaps reach some middle ground regarding your particular situation.
Posted in Issue of the Month and tagged Joseph Famiglietti.