Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 4 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER C - DRUGS: GENERAL
/ PART 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
/ Subpart E - Records and Reports / § 226.115 Complaint files.
§ 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.