Title 21

PART 111 SUBPART K

Subpart K - Production and Process Control System: Requirements for Manufacturing Operations

• 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
• 72 FR 34942, June 25, 2007, unless otherwise noted.

21:2.0.1.1.11.11.1.1	SECTION 111.353	111.353 What are the requirements under this subpart K for written procedures
21:2.0.1.1.11.11.1.2	SECTION 111.355	111.355 What are the design requirements for manufacturing operations
21:2.0.1.1.11.11.1.3	SECTION 111.360	111.360 What are the requirements for sanitation
21:2.0.1.1.11.11.1.4	SECTION 111.365	111.365 What precautions must you take to prevent contamination
21:2.0.1.1.11.11.1.5	SECTION 111.370	111.370 What requirements apply to rejected dietary supplements
21:2.0.1.1.11.11.1.6	SECTION 111.375	111.375 Under this subpart K, what records must you make and keep

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