1. Regulations
  2. title 21
  3. chapter I-i1
  4. part 111
  5. subpart N
  6. § 111.530

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