FDA 483 - Olon Active Pharmaceutical Ingredients India Private Ltd. - May 04, 2023

Olon Active Pharmaceutical Ingredients India Private Limited received a Form 483 for significant deficiencies in its manufacturing and laboratory operations. Issues included inadequate quality unit oversight, poor equipment maintenance, lack of data integrity controls, and failures in cleaning validation and stability testing programs. These conditions raise concerns about the quality and compliance of APIs and intermediates produced for the US market.