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
View all text of Subpart K [§ 111.353 - § 111.375]
§ 111.355 - What are the design requirements for manufacturing operations?

You must design or select manufacturing processes to ensure that product specifications are consistently met.

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