Alembic Pharmaceuticals has informed that the United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals Formulation Facility located at Panelav from 12th March, 2018 to 20th March, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with 3 observations. None of the observations are related to data integrity or repetitive in nature. The Company is preparing the response to the observations, which will be submitted to the US FDA shortly.
The above information is a part of company’s filings submitted to BSE.
