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

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 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.