§ 211.100 Written procedures; deviations.
Cited in 4 FDA warning lettersHow BatchGlow handles this
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
Cited in FDA warning letters
4 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.
- Woodbine Products Company Inc. · 27 Jul 2026
violation 2: 21 CFR 211.100(a) - Purolea Cosmetics Lab · 2 Apr 2026
violation 3: 21 CFR 211.100(a) - CDL Services, Inc. dba Technichem · 24 Nov 2025
violation 3: 21 CFR 211.100(a) - Columbia Cosmetics Manufacturing Inc. · 11 Sep 2025
violation 3: 21 CFR 211.100(a)
How BatchGlow handles this
Each batch is made to the approved version of the mixing procedure pinned to it. Moving a batch to another procedure version needs an approved change request and a signature, and a departure found during production is recorded as a deviation.
What it asks for, in plain words
- 21 CFR 211.100
- Written production and process control procedures, approved by the quality control unit, are followed and documented at the time each step is done. Any deviation from them is recorded and justified.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.