FDA 483 - Centurion Laboratories Private Limited - October 26, 2018

An FDA inspection of Centurion Laboratories Private Limited in Manjusar, Gujarat, revealed critical deficiencies in personnel training, equipment maintenance, and data integrity. The firm lacked adequate written procedures for cleaning and process controls, and numerous pieces of manufacturing equipment were found visibly dirty. Significant issues were also noted with computerized systems, including unauthorized access and the ability to delete raw data, alongside incomplete laboratory records and unperformed compendial testing for US-marketed products.