The FDA may conduct an FSVP inspection for different purposes. An investigator may audit your record because the importer has a history of violations or the produce you’re importing is associated with a recall. It is also possible that the FDA is simply auditing your FSVP because they are going through a routine surveillance.
Once the FDA investigator contacts you, the person in charge of the FSVP should prepare all relevant records. Depending on the FDA’s request, you may be able to send these documents electronically. Once the audit starts, the FDA investigator will ask your FSVP manager questions, take notes, and request copies of the relevant records. The FSVP agent must provide these documents promptly. All records must be translated into English.
The FDA officer will conclude the inspection with an exit interview. The investigator will show the FSVP manager some of their observations and, if needed, discuss corrective actions.
We can serve as your FSVP agent and can handle the entire audit on your behalf. If you do not designate us as the FSVP agent, we can still help. We can assist your FSVP representative prepare for the audit. We have helped hundreds of companies prepare for the FSVP audit. With 30+ years experience, we are adept at helping you go through any audit. Learn more about our FSVP agent services.
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