Can someone help me best understand this part of the FSVP regulations?
Is this saying that instead of an on-site audit, the written results of an inspection would suffice as long as the inspection was conducted within 1 year of when we WOULD have conducted on-site audit?
The following inspection results may be substituted for an onsite audit, provided that the inspection was conducted within 1 year of the date by which the onsite audit would have been required to be conducted:
(i) The written results of appropriate inspection of the foreign supplier for compliance with the applicable requirements in part 111 of this chapter conducted by FDA, representatives of other Federal Agencies (such as the USDA), or representatives of State, local, tribal, or territorial agencies;
The reason i ask is my company could never afford to send me overseas every time we needed to be the importer of record and create an FSV record for a new foreign supplier but if that foreign supplier hasn't had an inspection by one of the qualifying agencies above within the past year then what would be our other option? Either buy the plane ticket, not use the supplier or tell them we cant be the importer of record?
