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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
article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

The establishments 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 Shortageswas originally developed in 2014.

FDA 40