Nutrition Business Journal

11 Tips for Ensuring a Smooth FDA Inspection

  • Always be cooperative and honest with investigators. Never lie or make up an answer.

  • Create a standard operating procedure for virtually all company processes, and keep them up to date when a process is altered or modified.

  • Keep detailed records! All processes need to be documented. The FDA's rule is that if it wasn't written down, it wasn't done.

  • Keep up with the investigator's request for documents as much as possible. Commu

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