Code of Federal Regulations · Section
§ 111.375 — Under This Subpart K, What Records Must You Make And Keep?
21 C.F.R. § 111.375
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(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.
Authorizing Statute
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Regulations to control communicable diseases42 U.S.C. § 264
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Definitions; generally21 U.S.C. § 321