§ 211.198 Complaint files.
(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]
How BatchGlow handles this
Each complaint is recorded with its source, details, product and lot; a health complaint is triaged for a serious adverse event, and one that names neither product nor lot is saved with a request to add them when known.
What it asks for, in plain words
- 21 CFR 211.198
- Written procedures, followed in practice, govern every written and oral complaint about a drug product: the quality control unit reviews any complaint of a possible failure to meet specifications and decides whether to investigate it under § 211.192, and each complaint is reviewed for a serious and unexpected adverse drug experience that must be reported to the FDA. Each complaint is recorded in a drug product complaint file (where known the product and strength, lot number, complainant, nature of the complaint and reply; and either the investigation's findings and follow-up, or why none was made and who decided), kept at least 1 year past the expiration date or 1 year after receipt, whichever is longer (3 years after distribution for an OTC drug exempt from expiration dating).
These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.