21 CFR 111.453: What are the requirements under this subpart for M written procedures?
Requires dietary supplement manufacturers to establish and follow written procedures covering their holding and distributing operations, as the subpart's required written-procedures provision.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart M, Holding and Distributing
Recent 483s citing 111.453
- Miramar Cosmetics, Inc DBA Miramar Lab · Doral, FloridaYou did not establish procedures for holding and distributing operations… Aug 31, 2022
- Coating Place Inc. · Verona, WisconsinYou did not follow written procedures for holding and distributing operations… Mar 4, 2019
- The Aloe Source · Plano, TexasYou did not establish and follow written procedures for holding and distributing… May 20, 2016
The regulation text
§ 111.453 What are the requirements under this subpart for M written procedures?.
You must establish and follow written procedures for holding and distributing operations.
Questions
What does 21 CFR 111.453 require?
Requires dietary supplement manufacturers to establish and follow written procedures covering their holding and distributing operations, as the subpart's required written-procedures provision.
Which sections are cited alongside 111.453?
In the same 483s, investigators most often also cite 110.20 (Plant and grounds), 110.40 (Equipment and utensils), 111.103 (What are the requirements under this subpart F for written procedures?), 111.12 (What personnel qualification requirements apply?).