Alembic Pharmaceuticals has informed that the US Food and Drug Administration (USFDA) has conducted an inspection at the company’s API Facility located at Karkhadi from 13th January, 2020 to 17th January, 2020. This was a scheduled pre-approval inspection and at the end of the inspection, the USFDA issued a Form 483 with two observations.
The above information is a part of company’s filings submitted to BSE.