As of July 1st, the FDA has officially resumed surveillance inspections. As of this moment, the FDA claims they will give 1-2 days notice to the manufacturer of a pending surveillance inspection. Manufacturers have already been notified that “for cause” inspections have resumed earlier this year.
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According to FDA authorities, future FDA inspections will be comprehensive – many questions will be asked beyond standard gmp and haccp evaluations. Because of this change to the scope of FDA inspections, it will be crucial for the manufacturer to determine if the scope of the questions are relevant and if the inspector is skilled/trained to evaluate whether providing the information will compromise your proprietary information should the inspection be FOIAed (Freedom of Information Act request).
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For example, if an inspector asks you to prove your formula provides required nutrition for the appropriate life stage, how will you answer that question? Will you provide your exact recipe? Are you willing to risk someone will FOIA your inspection and obtain your exact recipe formulation?
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These are things we need to be thinking about, and if you have any questions, please contact me.
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Additional questions to consider:
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- Are your procedures in place?
- Do you have a continuing coronavirus policy?
- What are you doing to be prepared and confident in the face of an inspection?
