CFR › Title 21 › Part 111 › §111.37521 CFR §111.375Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗Copy link(a)You must make and keep records required under this subpart K in accordance with subpart P of this part.(b)You must make and keep records of the written procedures for manufacturing operations.