21 CFR · Food and Drugs
§ 226.115 — Complaint files.
21 CFR § 226.115
TitleTitle 21: Food and DrugsPartPart 226: Current Good Manufacturing Practice for Type a Medicated Articles
SourceeCFR (current through Apr 9, 2026)
This text of 21 C.F.R. § 226.115 (Complaint files.) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Bluebook
21 C.F.R. § 226.115 (2026).
Text
§ 226.115 Complaint files.
Records shall be maintained for a period of 2 years of all written or verbal complaints concerning the safety or efficacy of each Type A medicated article(s). Complaints shall be evaluated by competent and responsible personnel and, where indicated, appropriate action shall be taken. The record shall indicate the evaluation and the action.
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Nearby Sections
6
§ 226.42
Components.§ 226.58
Laboratory controls.§ 226.80
Packaging and labeling.§ 226.110
Distribution records.§ 226.115
Complaint files.Cite This Page — Counsel Stack
Bluebook (online)
21 C.F.R. § 226.115, Counsel Stack Legal Research, https://law.counselstack.com/cfr/21/226/226.115.