USFDA conducts inspection at Piramal Pharma's Bethlehem facility

Piramal Pharma Limited informed to the exchanges that the USFDA conducted a Good Manufacturing Practices (GMP) Inspection of company's Bethlehem facility from September 18, 2023 to September 27, 2023.

In a regulatory filing, the company mention that 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. 

Further, the Company is preparing a detailed response to said observations, which will be submitted to the US FDA 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 said in a statement.