21 CFR 211.180
General requirements
21 CFR 211.180 is the regulation titled “General requirements” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 39 FDA warning letters have cited it.
- Letters citing it
- 39 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 9 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 35 letters
- Closed out
- 3% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (38 of 39). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.180 most often, as written in the letters.
- 1 letterFailure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)] (see also 21 CFR 211.180(e)(2)). Our investigation found that…
- 1 letterFailure to establish and follow written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product [21 CFR 211.67(b)]. You do not…
- 1 letterFailure to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].** For example, you had not validated your process for cleaning and…
The regulation
Read the text of 21 CFR 211.180 (eCFR, as of Sep 1, 2026)
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch.
(b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling.
(c) All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph.
(d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available.
(e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:
(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.
(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product.
(f) Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under §§ 211.198, 211.204, or 211.208 of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.
[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.180.
- 21 CFR 211.22Responsibilities of quality control unit35 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures31 letters cite both
- 21 CFR 211.100Written procedures; deviations29 letters cite both
- 21 CFR 211.166Stability testing25 letters cite both
- 21 CFR 211.192Production record review18 letters cite both
- 21 CFR 211.165Testing and release for distribution16 letters cite both
- 21 CFR 211.188Batch production and control records16 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance16 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.180 that FDA posted most recently.
- DrugsView SnugZ USA, Inc.OTC drug products distributed as promotional itemsIssuedSep 28, 2026PostedOct 20, 2026
- DrugsView Silgan Dispensing Systemsnon-sterile over-the-counter (OTC) (b)(4) drug productsIssuedOct 5, 2026PostedOct 13, 2026
- DrugsView Spa De Soleil, Inc.OTC topical drug productsIssuedJul 8, 2026PostedJul 14, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.