USFDA conducts GMP Inspection at Piramal Pharma’s Bethlehem facility

29 Sep 2023 Evaluate

United States Food and Drug Administration (USFDA) has conducted a Good Manufacturing Practices (GMP) Inspection at Piramal Pharma’s Bethlehem facility from September 18, 2023 to September 27, 2023.

On conclusion of the inspection, a Form-483 was issued with 2 observations. Both observations relate to system improvement only, and none are related to data integrity. The company is preparing a detailed response to said observations, which will be submitted to the USFDA within stipulated timelines. The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all observations.

Piramal Pharma provides end-to-end pharma services to customers and a portfolio of differentiated pharma products across a domestic and global distribution network.


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