21 CFR 111.83: What are the requirements for reserve samples?
Manufacturers must keep identified reserve samples of each distributed packaged and labeled dietary supplement lot, in the distribution container-closure system, at least twice the quantity needed for testing, retained one year past shelf life or two years after distribution.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart E, Requirement to Establish a Production and Process Control System
Recent 483s citing 111.83
- Miramar Cosmetics, Inc DBA Miramar Lab · Doral, FloridaYou did not collect and hold reserve samples of packaged and labeled dietary… Aug 31, 2022
- Oasis Advanced Wellness, LLC · The Woodlands, TexasYou did not collect and hold reserve samples of packaged and labeled dietary… Feb 28, 2017
The regulation text
§ 111.83 What are the requirements for reserve samples?.
(a)You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute.
(b)The reserve samples must:
(1)Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere;
(2)Be identified with the batch, lot, or control number;
(3)Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and
(4)Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.
Questions
What does 21 CFR 111.83 require?
Manufacturers must keep identified reserve samples of each distributed packaged and labeled dietary supplement lot, in the distribution container-closure system, at least twice the quantity needed for testing, retained one year past shelf life or two years after distribution.
Which sections are cited alongside 111.83?
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?), 111.205 (What is the requirement to establish a master manufacturing record?), 111.255 (What is the requirement to establish a batch production record?).