FDA 483 - Ocean Healthcare Pvt Ltd - June 14, 2024

Ocean Healthcare Pvt Ltd, a manufacturer in Chengalpattu District, India, was cited for three significant issues during an FDA inspection. Observations included inadequate written procedures for complaint investigations, failure to test components for conformity, and a lack of written procedures for the quality control unit, specifically regarding chromatographic data management. These findings indicate deficiencies in quality control and adherence to established manufacturing practices.