21 CFR 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.
- 21 CFR 111.113 — What Quality Control Operations Are Required for a Material Review and Disposition Decision?
- 21 CFR 111.90 — What Requirements Apply to Treatments, In-Process Adjustments, and Reprocessing When There Is a Deviation or Unanticipated Occurrence or When a Specification Established in Accordance With § 111.70 Is Not Met?