21 CFR 111.77: What must you do if established specifications are not met?
Requires quality control personnel to reject components, packaging, labels, in-process materials, or finished products that fail specifications, unless they approve treatment, adjustment, or reprocessing that ensures quality, and to bar failed product from use or release.
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 111.77
- OHM Pharma, Inc · Mineral Wells, TexasYour Quality Assurance personnel approved and released for distribution a batch of… Mar 18, 2020
- Nutri-Dyn Midwest, Inc · Maple Plain, MinnesotaYour quality control personnel did not reject a dietaiy supplement for which a… Apr 10, 2015
The regulation text
§ 111.77 What must you do if established specifications are not met?.
(a)For specifications established under § 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. No finished batch of dietary supplements may be released for distribution unless it complies with § 111.123(b).
(b)For specifications established under § 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement.
(c)For specifications established under § 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement.
Questions
What does 21 CFR 111.77 require?
Requires quality control personnel to reject components, packaging, labels, in-process materials, or finished products that fail specifications, unless they approve treatment, adjustment, or reprocessing that ensures quality, and to bar failed product from use or release.
Which sections are cited alongside 111.77?
In the same 483s, investigators most often also cite 111.560 (What requirements apply to the review and investigation of a product complaint?), 111.70 (What specifications must you establish?).