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FDA Inspections Are Fact of Life



According to experts who spoke at the PMA Fresh Summit panel here earlier this month titled "Surviving an FDA Inspection: Preparation, Compliance and Action," unannounced inspections by Food and Drug Administration or state inspectors are a fact of life. Any facility along the supply chain from field to fork, including foodservice distributorships, that manufacture, process, pack, hold or transport produce, fish or dairy products are subject to an inspection, they pointed out.

"It makes perfect sense to conduct one or two mock inspections per year."
However, while the initial sound of the inspector's knock on the door may send shivers up and down managements' collective spine, the panelists also emphasized that produce growers and packers as well as distribution specialists or broadliners can survive a food regulatory review with a dose of preparation.

Their advice on how to do so can be found in a new guide that was prepared by the Produce Marketing Association in cooperation with the International Fresh-cut Product Association.

"We all agree on the fundamental – the produce industry is in the business of feeding the world healthy food and vegetables. Just one sick consumer, one foodborne pathogen outbreak is one too many," stated moderator Lorna Christie of the PMA.

While Mary Woleske of the FDA's Atlanta office, described the hows and whys of an inspection, the panelists who represented the industry repeatedly noted that each facility should have a written set of procedures that enumerates the company's food-safety policies and practices as well as the course of action that should be taken during an inspection.

Woleske indicated that in the course of an inspection, the FDA agents will ask questions and might even request samples.

"If a sample is collected, the inspectors will issue a receipt for the sample and they will offer to make payment. However, don't price gouge the government. Don't charge a million dollars for a couple of bags of produce," she sarcastically cautioned. Melvin Drozen, an attorney with Keller & Heckman who specializes in food regulatory matters, recommended that companies adhere to the following points when training for an inspection:

  • Organize a team or at least two employees who are trained to handle inspections;
  • In the course of the initial conference, find out why the FDA is inspecting your facility;
  • Take the inspector on the most direct route to where he or she wants to go;
  • Company contact should accompany the inspector at all times;
  • Be careful about what is posted in plain view;
  • If you do not allow photos, indicate that you are doing so as a matter of company policy;
  • If you receive a notice of objectionable conditions in FDA Form 483, you can make immediate corrections if you think it's appropriate but you need not respond at concluding meeting. However, you should always provide a written response to FDA Form 483, explaining what corrections were made or why you don't think corrections were necessary.

    Drozen urged companies in the food supply chain to be prepared and repeatedly rehearse what is trained. Furthermore, he said, know your rights and remember that the food regulatory inspector is not only in the facility to help the company but he's also the cop and detective on the case.

    "If there are potential problems, he or she is trying to build the case against you," he said.

    As for a written standard operating procedure manual that reflects the company's policies and rights, Drozen said management and employees should refer to it regularly.

    "It makes perfect sense to conduct one or two mock inspections per year and go over your documents with your responsible employees who are going to handle the inspection," he added.

    The federal government has additional regulatory authority under the Bioterrorism Act, though it hasn't yet exercised that mandate. According to this law, "if the FDA has reasonable belief that food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, the FDA may request all relevant records, e.g., shipment (trace back and forward), production, etc., that would allow the FDA to investigate this situation," Drozen said.

    Drozen also pointed out that employees have the right not to answer inspectors' questions, management doesn't have to sign any document, and inspectors are not allowed to take photographs of anything so, consequently, he added, "be careful of video cell phones." Dr. Robert Whitaker of NewStar Fresh Foods, LLC, emphasized the need for training and assigning roles to employees who will be directly responsible for escorting FDA inspectors on the review.

    "Have a fully documented and executed food safety program. Don't have a food safety program that sits on your shelf. If your employees don't understand it and you're not living it on a day-to-day basis, it does you no good. Make sure you're using the program," Whitaker advised. "Know your rights and support them with written policies. It's important that you understand what could take place during an inspection. Know how you're going to respond to an inspection and train your employees appropriately. Give them talking points so that they have the latest information, which they can share with your customers."

    Occasionally a supply chain company could become involved in a trace back investigation, which searches for reasons of pathogen contamination. In that case, Whitaker continued, in addition to sharing the necessary documentation with the FDA, companies must assign someone the task of handling the media and customers. Furthermore, inasmuch as the government won't attempt to exonerate anyone in the supply chain, companies under investigation will have to do that themselves.

    "Internal communications should be part of your plan. Make sure that you have a mechanism to talk to employees," he said.

    Whitaker and Drozen advised the supply chain partners that as they take advantage of their rights during an inspection, they should conduct themselves in a non-adversarial manner.

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