---
kind: "section"
citation: "21 C.F.R. § 226.115"
title: "21"
number: "226.115"
heading: "Complaint files."
url: "https://uscodex.org/cfr/21/226.115"
---

# §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.


## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 360b, 371, 374.

### Source

Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.