21 CFR 111.553: What are the requirements under this subpart O for written procedures?
Requires dietary supplement manufacturers to establish and follow written procedures covering all product complaint requirements, including review, investigation, and recordkeeping, under the subpart on product complaints.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart O, Product Complaints
Recent 483s citing 111.553
- Safrel Pharmaceuticals LLC · Dayton, New JerseyYou did not establish written procedures for the requirements to review and… Jan 30, 2026
- Miramar Cosmetics, Inc DBA Miramar Lab · Doral, FloridaYou did not establish written procedures for the requirements to review and… Aug 31, 2022
- United Laboratories Manufacturing, LLC · Carrollton, TexasYou did not follow written procedures for the requirements to review and… Aug 12, 2010
The regulation text
§ 111.553 What are the requirements under this subpart O for written procedures?.
You must establish and follow written procedures to fulfill the requirements of this subpart O.
Questions
What does 21 CFR 111.553 require?
Requires dietary supplement manufacturers to establish and follow written procedures covering all product complaint requirements, including review, investigation, and recordkeeping, under the subpart on product complaints.
Which sections are cited alongside 111.553?
In the same 483s, investigators most often also cite 111.103 (What are the requirements under this subpart F for written procedures?), 111.12 (What personnel qualification requirements apply?), 111.453 (What are the requirements under this subpart for M written procedures?), 111.455 (What requirements apply to holding components, dietary supplements, packaging, and labels?).