FDA 483 - Gland Chemical Private Limited - April 03, 2018

This 483 report for Hospira Healthcare India Pvt. Ltd. details significant quality control and manufacturing deficiencies. The firm failed to ensure cGMP compliance, manipulated laboratory data, and released drug products that did not meet specifications. Repeated observations from previous inspections indicate a systemic lack of adequate investigation, process control, and method validation, leading to distributed out-of-specification products and potential patient safety risks.