Section 25.23. Complaint files

Latest version.

Records shall be maintained of all written and oral complaints regarding each product. An investigation of each complaint shall be made in accordance with § 25.16(8) (relating to production and control procedures). The record of each investigation shall be maintained for at least 2 years after distribution of the drug has been completed or 1 year after the expiration date of the drug, whichever is longer.

                    
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