FDA 483 - Curia India Private Limited - February 16, 2024

An FDA inspection of Curia India Pvt. Ltd. in Aurangabad, India, identified deficiencies in the firm's laboratory methods and procedures. The inspection revealed issues with the preparation of secondary reference standards, outdated written procedures for primary standard procurement, and a lack of scientific justification for retesting during out-of-specification investigations. These findings indicate a need for improved quality control in laboratory operations.