The inspection was conducted at the Karkhadi new injectable facility from January 29 to February 5, 2021
Alembic Pharmaceuticals said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat.
“The United States Food and Drug Administration (US FDA) 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 US FDA issued a form 483 with 5 observations, the company said in a regulatory filing.
As per the US FDA, a Form 483 is issued to a firm”s management after 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.
“The company is preparing the response to the observations, which will be submitted to US FDA shortly,” the company said.