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Alembic Pharma's Karkhadi unit receives 1 observation from USFDA

Press Trust of India  |  New Delhi 

Pharmaceuticals today said the US health regulator has issued one observation on inspection of the company's in

As per a BSE filing by Alembic, USFDA conducted the inspection at (API) facility at Karkhadi from May 14-18, 2018.

"This was a scheduled inspection and at the end of the inspection, USFDA issued a Form 483 with one observation," the company said.

is preparing the response to the observation, which will be submitted to the Food and Drug Administration (USFDA) shortly, it said.

As per USFDA, Form 483 is issued at the conclusion of an inspection, notifying a company's management of objectionable conditions at the facility.

Shares of Pharmaceuticals today settled at Rs 465 per scrip on BSE, down 2.23 per cent from the previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, May 18 2018. 17:55 IST