Is FDA allowed to take photography in the production area

The big question is:  "Is FDA allowed to take photography in the production area.  I have hear both side of this story.  Feedback would be great. 

Although that is a different type of relationship that the FDA, USDC often takes photos to compile their SIP report for export health certification.   Personally, I've never had an FDA inspector take a photo... but a great question to be proactive on and how to address it when it suddenly happens. "allowed" is an interesting term when it comes to regulatory authorities, I'd talk to your companies legal dept.

-B

It has been held up (and supported by the new inspection powers grated by FSMA) that FDA has legal authority to take photos in an establishment. However, they aren't supposed to take them without cause. So an inspector can't just snap pictures of your entire facility to dissect later, they need to take pictures of a violation, sampling site, or other specific reason.

From the guidance for drug inspections, which includes the same area of the law: https://www.fda.gov/...s/UCM360484.pdf

B. Limiting Photography Photographs are an integral part of an FDA inspection because they present an objective and contemporaneous representation of facility conditions. Examples of conditions or practices effectively documented by photographs include, but are not limited to: 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 raw materials or finished products. 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.

 

From the inspections operations manual:https://www.fda.gov/...M/UCM150576.pdf

5.3.4.1 - In-Firm Photographs Do not request permission from management to take photographs during an inspection. Take your camera into the firm and use it as necessary just as you use other inspectional equipment. Only FDA issued cameras are to be used in official business. If management objects to taking photographs, explain that photos are an integral part of an inspection and present an accurate picture of firm conditions. If management of a drug firm does not give a reasonable explanation for its objection, such as a showing that the chemical properties of products manufactured at the facility are such that taking photographs would adversely affect product quality, you may advise management that the refusal may constitute a limiting of the inspection under Section 501(j) [21 U.S.C. 551(j)] of the FD&C. Advise management the U. S. Courts have held that photographs may lawfully be taken as part of an inspection. If management continues to refuse, provide them with the following references: 1. "Dow Chemical v. United States”, 476 U.S. 227 (1986) This Supreme Court Decision dealt with aerial photographs by EPA, but the Court's language seems to address the right to take photographs by any regulatory agency. The decision reads in part, "** When Congress invests an agency with enforcement and investigatory authority, it is not necessary to identify explicitly each and every technique that may be used in the course of executing the statutory mission. ***" 2. "United States of America v. Acri Wholesale Grocery Company, A Corporation, and JOSEPH D. ACRI and ANTHONY ACRI, Individuals", U.S. Division Court for Southern Division of Iowa. 409 F. Supp. 529. Decided February 24, 1976. If management refuses, obtain name and contact information for the firm’s legal counsel, and advise your program division management immediately. If the firm does not have legal counsel on retainer, collect the name and contact information for the most responsible individual. Program division management will inform their ORA Regional Counselor in the Office of Chief Counsel (OCC) of the situation, and OCC will then contact the firm’s legal counsel or most responsible individual todiscuss FDA’s legal right to take pictures during inspections. OCC will relay the results of this conversation to program division management. If you have already taken some photos do not surrender film to management. Advise the firm it can obtain copies of the photos under the Freedom of Information Act. See IOM 5.3.4.5.

 

Further, this is also why FDA generally won't sign visitor forms. See this thread for more details: http://www.ifsqn.com...visitor-policy/

Yes they are allowed to take photos of violations but you can and should take the exact same picture as the FDA Inspector for your own company records so that if necessary for further actions your company has a comparable photo.

Yes they are allowed to take photos of violations but you can and should take the exact same picture as the FDA Inspector for your own company records so that if necessary for further actions your company has a comparable photo.

I second that advice.

You have the right to restrict the field of view to not include proprietary information unless it is part of the violation. They can't just take a wide angle shot of your entire building, as it could be accessed through a FOIA request by a competitor.

I suspect that any reasonable request to narrow the field to the violation would be complied with, as long as you do not try to stop them from taking the pictures altogether. Working with the inspector usually gets you the cooperation that you need to protect your IP.

Martha