Code of Federal Regulations · Section
§ 111.355 — What Are The Design Requirements For Manufacturing Operations?
21 C.F.R. § 111.355
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You must design or select manufacturing processes to ensure that product specifications are consistently met.
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