Aarti Drugs gets 7 inspectional USFDA observations for Tarapur facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-23 05:30 GMT | Update On 2024-09-23 05:30 GMT
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Maharashtra: Aarti Drugs Limited has announced that the United States Food and Drug Administration (US FDA) has issued 7 inspectional observations in Form 483 for the API manufacturing facility of the Company at Plot No. E-22, MIDC, Tarapur, Maharashtra.
The inspection was conducted from 12th to 20th of September 2024.
"On conclusion of the inspection, the company has received 7 inspectional observations in Form 483, where none of the observations are related to Data Integrity," the Company stated in a BSE filing.
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 will work closely with US FDA in resolving all points. There is no impact on financial, operation or other activities of the Company pursuant the observations received," it added.
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