21 C.F.R. § 226.115 Complaint files.
Title 21 - Food and Drugs
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: Food and Drugs
PART 226—CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
Subpart E—Records and Reports
§ 226.115 Complaint files.
