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.
21 CFR Part 226 · Current Good Manufacturing Practice for Type a Medicated Articles
§ 226.115 Complaint files
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 226.115
Form FDA 483 observations citing this section, fiscal years 2014–2024 (Veterinary Medicine).
- Appropriate action not taken 2
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 14031 27 Mar 1975
- 89 FR 51777 18 Jun 2024