You are required to keep FSVP records, but are not required to send them 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)).
If requested, you must make all records required under this subpart (21 CFR 1.510) available promptly to an authorized FDA representative for inspection and copying. Upon FDA request, you must provide an English translation of records maintained in a language other than English within a reasonable time (21 CFR 1.512(b)(5)(ii)(A)).
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. Electronic records are onsite if they are accessible from an onsite location. (see 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)).
