FDA Inspections
Avoid the dreaded Form 483 by ensuring your facility meets FDA regulations
The FDA has the authority to conduct inspections of U.S. facilities without a warrant. Even foreign facilities are subject to inspection. Manufacturers, distributors, repackagers, relabelers, and specification developers in the dietary supplement, food, drug, medical device, or animal drug or food industries can be inspected at any time.
Any minor violations the FDA notices are written on Form 483 Inspection or Inspectional Observations. Major violations will receive a Warning Letter.
The FDA field agent conducting the inspection notes whether your facility meets the Good Manufacturing Practices (GMP) outlined by the FDA. It’s important to make sure that your products are not adulterated or improperly labeled. Serious violations can lead to a recall, which can be devastating for many businesses.
If you receive a Form 483, you must respond within 15 days of the inspection. Your response is evaluated by a Compliance Officer, who decides on the next steps, which can include a Warning Letter, recall, seizure, or in a serious case, an injunction.
With a breadth of FDA experience helping clients navigate inspection enforcement, we can help you prepare a response to Form 483 so you can get back to growing your business.
Don’t delay — you only have 15 days to respond once you’ve been inspected.
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