21 CFR 111.103: What are the requirements under this subpart F for written procedures?
Requires dietary supplement manufacturers to establish and follow written procedures for quality control responsibilities, including material review and disposition decisions and approval or rejection of any reprocessing.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart F, Production and Process Control System: Requirements for Quality Control
Recent 483s citing 111.103
- Safrel Pharmaceuticals LLC · Dayton, New JerseyYou did not establish written procedures for quality control operations… Jan 30, 2026
- Miramar Cosmetics, Inc DBA Miramar Lab · Doral, FloridaYou did not establish written procedures for quality control operations… Aug 31, 2022
- Primrose Candy Company · Chicago, IllinoisYou did not follow written procedures for quality control operations… Feb 25, 2021
- Wasatch Product Development, LLC · Draper, UtahYou did not establish and follow written procedures for quality control operations… Apr 9, 2019
- Primrose Candy Company · Chicago, IllinoisYou made an in-process adjustment to a component of a dietary supplement for which… May 23, 2012
The regulation text
§ 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.
Questions
What does 21 CFR 111.103 require?
Requires dietary supplement manufacturers to establish and follow written procedures for quality control responsibilities, including material review and disposition decisions and approval or rejection of any reprocessing.
Which sections are cited alongside 111.103?
In the same 483s, investigators most often also cite 111.553 (What are the requirements under this subpart O for written procedures?), 111.113 (What quality control operations are required for a material review and disposition decision?), 111.12 (What personnel qualification requirements apply?), 111.210 (What must the master manufacturing record include?).