Piramal Pharma gets 2 USFDA observations for Lexington facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-26 10:33 GMT | Update On 2024-03-21 10:07 GMT
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Mumbai: Piramal Pharma has announced that the US Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection (PAI) with 2 observations of the Company's Lexington (USA) facility for one of the product expected to be manufactured at this facility.
The inspection was conducted from 20th February, 2024 to 23rd February, 2024.
On conclusion of the inspection, a Form-483 was issued with 2 observations. 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 observations does not pose any risk to site’s compliance standards or its business continuity. The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines," the Company added.
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