21 CFR 226.115 - Complaint files.
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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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.