FDA 483 - Jubilant Generics Limited - March 12, 2021

Jubilant Generics Ltd. in Hardwar, India, received a Form 483 with seven observations related to significant deficiencies in manufacturing controls. Issues included inadequate equipment cleaning and maintenance, deficient cleaning validation, insufficient investigation of product defects, and failures in validating automated inspection equipment. Furthermore, the firm demonstrated poor data integrity practices, including inadequate data backups and control over computerized systems, alongside a quality control unit lacking sufficient authority and resources.