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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 111Subpart K - Subpart K—Production and Process Control System: Requirements for Manufacturing Operations
§ 111.353 - What are the requirements under this subpart K for written procedures?
§ 111.355 - What are the design requirements for manufacturing operations?
§ 111.360 - What are the requirements for sanitation?
§ 111.365 - What precautions must you take to prevent contamination?
§ 111.370 - What requirements apply to rejected dietary supplements?
§ 111.375 - Under this subpart K, what records must you make and keep?
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