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USFDA to conduct physical audit of Alembic’s Karakhadi plant

The US Food and Drug Administration (USFDA) is set to conduct a physical audit of Alembic’s Karakhadi plant in Gujarat that manufactures general injectable and ophthalmic products. The inspection is expected to begin today or tomorrow, sources told CNBC-TV18.

The US Food and Drug Administration (USFDA) is set to conduct a physical audit of Alembic’s Karakhadi plant in Gujarat that manufactures general injectable and ophthalmic products. The inspection is expected to begin today or tomorrow, sources told CNBC-TV18.
The plant will be inspected by two to three USFDA auditors, who are expected to be from India, the sources added.
This will be the first inspection of Alembic’s Karakhadi plant by USFDA.
According to the sources, the USFDA will undertake a pre-approval inspection (PAI) of certain injectables filed by the company in the US.
This is likely to be one of the first few physical audits conducted by the USFDA auditors after the COVID-19 outbreak.
Alembic is yet to respond to CNBC-TV18's queries.
Watch the video for more details