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USFDA issues EIR to Piramal Pharma’s USA facility

23 May 2024 Evaluate

United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) to Piramal Pharma’s manufacturing facility located at Lexington, USA. The inspection has now been successfully closed by the USFDA.

Earlier, USFDA had conducted a Pre-Approval Inspection (PAI) inspection at said facility from February 20, 2024 to February 23, 2024 for one of the product expected to be manufactured at this facility. On conclusion of the inspection, a Form-483 was issued with 2 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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