21 CFR § 111.530 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

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

Current through Sep 8, 2026 · Read all of Part 111

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.

← § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?§ 111.535 Under this subpart N, what records must you make and keep? →