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21 CFR 226.115

§ 226.115 Complaint files.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 226.115, § 226.115 Complaint files, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86129
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.