USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

By: IPP Bureau

Last updated : February 21, 2025 8:25 pm



Observations are largely around improvement of procedures and practices


The USFDA conducted General GMP inspection at Piramal Pharma Limited's Turbhe facility from 11th February, 2025 to 17th February, 2025.

On conclusion of the inspection, a Form-483 was issued with 6 observations. Observations are largely around improvement of procedures and practices and not related to data integrity. The Company is preparing a detailed response to said observations, which will be submitted to agency within stipulated timelines.

Piramal Pharma USFDA

First Published : February 21, 2025 12:00 am