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Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its center at Karkhadi, Gujarat.
“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 close of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing.
According to 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 informs the company”s management of objectionable conditions.
Alembic Pharma said none of those observations were associated with data integrity and were procedural in nature.
“The company is preparing the answer to the observations, which will be submitted to USFDA shortly,” the company said.
Shares of Alembic Pharmaceuticals were trading 0.44 percent higher at Rs 935.95 apiece on BSE.
