21 CFR 211.198
Complaint files
21 CFR 211.198 is the regulation titled “Complaint files” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 24 FDA warning letters have cited it.
- Letters citing it
- 24 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 211.192, in 13 letters
- Closed out
- 4% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (19 of 24). 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 211.198 most often, as written in the letters.
- 2 lettersYour firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of…
- 1 letterFailure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine the appropriate storage…
- 1 letterFailure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine the appropriate storage…
The regulation
Read the text of 21 CFR 211.198 (eCFR, as of Sep 1, 2026)
(a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with § 211.192. Such procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration in accordance with §§ 310.305 and 514.80 of this chapter.
(b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. Written records involving a drug product shall be maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer. In the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, such written records shall be maintained for 3 years after distribution of the drug product.
(1) The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant.
(2) Where an investigation under § 211.192 is conducted, the written record shall include the findings of the investigation and followup. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with § 211.180(c).
(3) Where an investigation under § 211.192 is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.
[43 FR 45077, Sept. 29, 1978, as amended at 51 FR 24479, July 3, 1986; 68 FR 15364, Mar. 31, 2003]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.198.
- 21 CFR 211.192Production record review13 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit12 letters cite both
- 21 CFR 211.100Written procedures; deviations11 letters cite both
- 21 CFR 211.165Testing and release for distribution10 letters cite both
- 21 CFR 211.188Batch production and control records9 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures8 letters cite both
- 21 CFR 211.113Control of microbiological contamination7 letters cite both
- 21 CFR 211.160General requirements7 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.198 that FDA posted most recently.
- DrugsView Conroe Welding Supply, Inc.Oxygen, USP for administration by inhalationIssuedOct 29, 2026PostedNov 3, 2026
- BiologicsView R3 Medical Companiesumbilical cord derived products (ReBellaWJ, ReBellaXO, ReBellaXOL, ReBellaCB)IssuedAug 14, 2026PostedAug 25, 2026
- DrugsView Lico Industries, LLC., d.b.a. American Towelette Companyover-the-counter (b)(4) drug productsIssuedJul 30, 2026PostedAug 11, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.