Code of Federal Regulations · Section
§ 111.530 — When Must An Investigation Be Conducted Of Your Manufacturing Processes And Other Batches?
21 C.F.R. § 111.530
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If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.
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