As a very small importer subject to the FSVP rule, you are required to keep FSVP records in accordance with 21 CFR 1.512(b)(5). However, you are not required to send your records to FDA unless FDA requests, in writing, that you send your records (see 21 CFR 1.512(b)(5)(ii)(C)). (FDA may also request you to make your records available for inspection and copying at your place of business (see 21 CFR 1.512(b)(5)(ii)(A) ).
As specified in 21 CFR 1.512(b)(5)(i)(A), you must keep FSVP records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records. You must sign and date your records upon initial completion and upon any modification (21 CFR 1.512(b)(5)(i)(B) ). All required records must be legible and stored to prevent deterioration or loss (21 CFR 1.512(b)(5)(i)(C) ) You must retain your FSVP records for at least 2 years after you created or obtained the records (21 CFR 1.512(b)(5)(iii)(A) ). However, with respect to records that support your status as a very small importer, you must retain for at least 3 years records that you rely on during the 3-year period preceding the applicable calendar year (21 CFR 1.512(b)(5)(iii)(C) ).
Offsite storage of records, including records maintained by other entities in accordance with the FSVP regulation is permitted if the records can be retrieved and provided onsite within 24 hours of request for official review (21 CFR 1.512(b)(5)(ii)(B) ). Electronic records are onsite if they are accessible from an onsite location (21 CFR 1.512(b)(5)(ii)(B) ).
If requested in writing by FDA, you must send records to the Agency electronically, or through another means that delivers the records promptly, rather than making the records available for review at your place of business (21 CFR 1.512(b)(5)(ii)(C) ).
