Know your rights during an FDA inspection
It is essential for dairy companies to know where FDA’s authority ends
Food Safety Modernization Act (FSMA) regulations represent a paradigm shift in how food is regulated in the United States to protect consumers from foodborne illness. The act and its corresponding regulations not only place more responsibility on food manufacturers, but also provide FDA with substantial new authority to use when inspecting facilities.
As FDA has shifted its focus to implementing the FSMA regulations and inspecting against those standards, it is essential for dairy companies to know where FDA’s authority ends and to be well prepared for FSMA inspections. Two of the most commonly asked questions we receive revolve around FDA’s authority over records access and photography during inspections.
Historically, FDA investigators and state inspectors working on behalf of FDA had very limited rights to demand access to company records during routine inspections. FSMA significantly changed this approach by granting FDA substantial records access. Now, investigators can access and copy a facility’s Food Safety Plan (FSP) and other records relating to the manufacturing, processing, packing and holding of food.
FDA is energized and ready to use its new records access authority because these records help the agency determine how a company operates when investigators are not present. In general, FDA investigators may review and copy all records associated with your FSP, including a facility’s hazard analysis, descriptions of preventive controls, environmental and product testing records, and corrective actions records.
They are not entitled to review or copy the following types of records: recipes, sales or pricing information, financial data, product research and consumer complaint information, if not included within the FSP. However, they may request these documents; therefore, facility representatives should be prepared to respectfully decline access, when appropriate, to ensure FDA is not accessing records that are outside of its legal authority.
A picture says 1,000 words
Requests for photography may be handled the same way. A company is not required to allow FDA to take photographs during an inspection, but it may choose to do so.
Although FDA investigators are adamant that they have a right to take photographs during inspections, neither the Federal Food, Drug and Cosmetic Act nor case law provides definitive legal authority to do so. FSMA did not change this. Nonetheless, FDA investigators are instructed to take photographs without permission and to press the matter even if the company objects.
FDA uses photographs to help supplement observations in its inspection reports, document deviations from good manufacturing practices and record where environmental swabs were collected. Companies are understandably leery of photography because a photo could capture proprietary aspects of a facility, could cause a safety hazard in some circumstances or may be taken out of context and used in court against the company.
We strongly recommend that all companies, working closely with their legal counsel, establish a firmwide policy with respect to the taking of photographs or video recordings inside their facilities. If your company adopts a policy that prohibits photography, the policy should be clearly, but respectfully, explained to the investigator during the pre-inspection meeting to head off any attempts to bring a camera onto the production floor. Additionally, your representative should clearly convey that the facility is not refusing an inspection; it is merely following company policy.
If your company decides to allow photography by an FDA investigator, a facility representative should take similar photos to develop your own record of inspection and possibly generate additional context for the photos, if necessary.
As FDA follows its mantra “to educate before and while we regulate,” IDFA encourages dairy food companies to understand their rights and be prepared before an inspection occurs. Doing so will help ensure inspections proceed more smoothly — for both the company employees and FDA investigators.