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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The establishment’s document control/record management system was not sufficient. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages, May 2024 PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014.

FDA 52