On Friday, Bajaj Healthcare Ltd said it has successfully completed a pre-approval inspection by US health regulators at its active pharmaceutical ingredient plant in Vadodara, Gujarat.
The regulatory filing says that from November 14, 2022, to November 17, 2022, USFDA will come for a pre-approval inspection at Bajaj Healthcare Ltd (BHL).
The company manufactures APIs (active pharmaceutical ingredients), intermediates and formulations; it said the FDA pre-approval inspection was successfully completed with zero Form 483 observations at the manufacturing facility.
Form 483 is issued to corporate management after the inspection when investigators discover anything that may constitute a violation of the Food, Drug, and Cosmetic (FD&C) Act and related acts.
