1. Regulations
  2. title 21
  3. chapter I-i1
  4. part 111
  5. subpart F
  6. § 111.103

View all text of Subpart F [§ 111.103 - § 111.140]

§ 111.103 - What are the requirements under this subpart F for written procedures?

You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.

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 111.103