---
kind: "section"
citation: "21 C.F.R. § 111.530"
title: "21"
number: "111.530"
heading: "When must an investigation be conducted of your manufacturing processes and other batches?"
url: "https://uscodex.org/cfr/21/111.530"
---

# §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.


## Notes

### Authority

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

### Source

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