§111.530. When must an investigation be conducted of your manufacturing processes and other batches?
21 C.F.R. § 111.530
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, amendments, and revision history
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.