Food Inspection: Prepare In Advance, In Case FDA Knocks On Your Door

No one would want to receive a call from the FDA announcing an upcoming inspection. Still, food and drug manufacturers are very well aware of the significance of FDA inspections, even they are touted as a necessary burden they must endure to get the FDA approval in order to sell their products into the U.S. market.

The FDA is supposed to contact you in the event of an advance inspection; they will inform you the purpose as well as the estimated duration, and number of FDA personnel that are expected to partake in the process. On the inspection day, the FDA investigator will try to locate the top management official at the intended site. They must show their credentials to that official, and also present you with an FDA Notice of Inspection, following which the inspection authority will perform a thorough inspection of your facility; the investigator will be accompanied by one or more of your employees. After this, within a reasonable period of time, post the actual inspection, the FDA will send members of your top management an Inspection Observations form that will inform you of the objectionable conditions pertaining to the products or processes or other violations to the FD&C Act and related Acts.

The outcome of the FDA inspection will either include no required actions or even a complete shutdown of your facility inclusive of administrative, civil and even criminal actions levied against you. In most of the cases, the FDA will give suggestions on how you can improve your operations so that they are compliant with the FD&C Act.

To prepare for the next food regulatory inspection, it is advisable to conduct regular internal FD&C Act compliance check. The best way to prepare in advance for FDA inspection is to ensure that the facility is compliant with the FDA regulations. Every employee in your organization should be aware of the standards that the products and processes for which they are responsible must meet in order to be FD&C Act-compliant. Plus, the employees should be well-trained to retain their composure and be courteous to FDA inspectors, along with complying with their requests. At the same time, your employees must know their rights in terms of what they are required to say or show to the FDA inspector and (as well as what they are not).

You must also identify and attend to potential weak spots. It would be wise to identify potential areas or even processes in your facility that can attract the FDA attention during food regulatory inspection. You should ask yourself: Which of the processes can pose the most potential for contamination of the food, drugs or other consumable materials we are processing? What are the areas in your facility that appear to be under-maintained, unclean or potentially faulty? When the FDA will attempt to thoroughly inspect your entire facility, it is a possibility that they will be most thorough in inspecting such potential problem areas.

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