New Delhi: Alembic Pharmaceuticals said the US health regulator has issued one observation on inspection of the company’s Karkhadi facility in Gujarat.
As per a BSE filing by Alembic, USFDA conducted the inspection at active pharmaceutical ingredient (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.
Alembic is preparing the response to the observation, which will be submitted to the United States 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.