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Code · CFR · Title 21 — Food and Drugs · Part 226 — Current Good Manufacturing Practice for Type a Medicated Articles · § 226.115

§ 226.115. Complaint files.

53 words·~1 min read·/us/cfr/t21/s§ 226.115·

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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.
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