Bajaj Healthcare Ltd. on Friday said it has successfully completed the U.S. health regulator's pre-approval inspection of its active pharmaceutical ingredients facility located at Vadodara in Gujarat.
The U.S. Food and Drug Administration had conducted a pre-approval inspection of the facility from Nov. 14, 2022, to Nov. 17, 2022, Bajaj Healthcare said in a regulatory filing.
The pre-approval inspection has completed successfully with zero Form 483 observations of the manufacturing facility, said the company, which is a manufacturer of APIs, 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 Act and related Acts.
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