Indian pharmaceuticals manufacturer Dr Reddy’s Laboratories Ltd said the US FDA has issued a Form 483 after auditing its Miryalaguda plant in Telangana.
A Form 483 is issued when inspectors notice discrepancies in the policies and practices followed in a manufacturing facility vis-a-vis the good manufacturing practices laid down by the US drug regulator.
Companies are expected to respond to the Form 483 with a mitigation strategy to avoid any further action from the part of the US Food & Drug Administration, such as blocking all products from the facility from entering the US market.
Dr Reddy’s, a major exporter of drugs and drug ingredients (APIs) to the US market, said the issued Form 483 contains only one observation. It said it is addressing the same.
Founded by Anji Reddy, Dr Reddy’s has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.
It started as a supplier to Indian drug manufacturers, but it soon started exporting to other markets.
By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies.