21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart N [§ 111.503 - § 111.535]

§ 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications.

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 111.530