Going through the FSVP audit can be stressful. To help prepare you for the audit, here is a list of frequently asked questions.
1) Why will the FDA audit my shipment?
There are several reasons why the FDA may conduct an FSVP inspection.
- The FDA may audit your FSVP records for routine surveillance or follow up purposes.
- If the importer has a history of violation(s), the FDA may conduct an inspection to ensure that all corrections have been made.
- The FDA may conduct an audit if the products you are importing are associated with a foodborne illness outbreak, recall, or complaint.
2) How will I hear from the FDA?
An investigator will first email or call the FSVP importer. The FDA will contact the importer at the time of entry. If the FSVP importer cannot be reached (by phone or email), the investigator will continue their search regardless, investigating the FSVP importer at the address provided during entry.
3) How can I prepare for the audit?
The person in charge of the FSVP should first gather all relevant records and ensure that they are in English. Please contact us to see which records should be prepared for the audit.
4) Where will the audit take place?
The FDA investigator will sometimes conduct the audit at the FSVP’s address. Other times, the FDA will conduct the inspection remotely.
5) What will happen during the audit?
The investigator will first ask to speak with the individual responsible for managing the FSVP. The FDA investigator will often request relevant records. They will ask the FSVP manager questions, take notes, and request copies of the relevant records.
6) How will the audit conclude?
The investigator will conclude the inspection with an exit interview. They will show the FSVP manager some of their observations and discuss corrective actions.
Prior to entry, you can designate us as your FSVP agent. We 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 the FSVP representative and help them prepare for the audit. Whether you use Ken Lehat & Associates as your FSVP agent or another entity, we can help you get through the audit. We have helped hundreds of companies prepare for the FSVP inspection. With 30+ years experience, we are adept at helping you go through any audit. For more information about the audit contact us.
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