USFDA issues 6 observations for Piramal Pharma Turbhe facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-19 07:00 GMT | Update On 2025-02-19 07:00 GMT
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Mumbai: Piramal Pharma has announced that the Company has received six observations from US Food and Drug Administration (USFDA) at the conclusion of the inspection at the Turbhe facility.
The US FDA conducted General GMP inspection 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 stated.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company is preparing a detailed response to said observations, which will be submitted to agency within stipulated timelines. The Company remains committed to maintain a highest standards of compliance and is confident of effective closure of observations," Piramal Pharma said in a BSE filing.
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