Preparing for FDA Inspection

No one was waiting for a call from the FDA announcing the upcoming inspections. However, food and drug manufacturers understand that FDA inspections are a burden they must bear to maintain FDA approval in order for their products to be sold on the US market.

You may browse this site if you want to know about the FDA inspection.

The FDA should contact you prior to the inspection and inform you of the destination, estimated duration, and number of FDA personnel expected to attend. On the day of the inspection, FDA examiners will try to discover top management on your site.

You must provide your credentials to this officer and notify the FDA for review. At this stage, the inspection body will perform a thorough inspection of your facility, accompanied by one or more of your staff.

Within a reasonable time after the actual inspection, the FDA will send a member of your senior management an inspection surveillance form notifying you of any adverse conditions associated with a product or process or other violations of FD&C laws and information relating to their statute.

The results of an FDA inspection can range from unnecessary acts to complete suspension of your facility, accompanied by administrative, civil, or criminal action against you. In most cases, the FDA will make recommendations about how to improve your operations to comply with the FD&C Act.