21 CFR 111.103 - What are the requirements under this subpart F for written procedures?

Regulations last checked for updates: Dec 17, 2025

Title 21 - Food and Drugs last revised: Dec 11, 2025

View all text of Subpart F [§ 111.103 - § 111.140]

§ 111.103 - What are the requirements under this subpart F for written procedures?

You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.

authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.

source: 72 FR 34942, June 25, 2007, unless otherwise noted.

cite as: 21 CFR 111.103