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Alembic Pharma gets five observations from USFDA for Gujarat facility

Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat

Alembic Pharmaceuticals | USFDA | Gujarat

Press Trust of India  |  New Delhi 

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Alembic Pharmaceuticals

on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi,

"The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021.

This was a scheduled inspection and at the end of the inspection, the issued a form 483 with 5 observations, the company said in a regulatory filing.

As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions.

Alembic Pharma said none of the observations were related to data integrity and were procedural in nature.

"The company is preparing the response to the observations, which will be submitted to shortly," the company said.

Shares of were trading 0.44 per cent higher at Rs 935.95 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Mon, February 08 2021. 11:57 IST