Bajaj Healthcare Ltd on Friday said it has successfully completed the US health regulator's pre-approval inspection of its active pharmaceutical ingredients facility located at Vadodara in Gujarat.
The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection of the facility from November 14, 2022, to November 17, 2022, Bajaj Healthcare Ltd (BHL) said in a regulatory filing.
The pre-approval inspection of USFDA has completed successfully with zero Form 483 observations of the manufacturing facility, said the company, which is a manufacturer of APIs (active pharmaceutical ingredients), intermediates and formulations.
Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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