FDA 483 - Eugia Pharma Specialities Limited - April 28, 2017

Aurobindo Pharma Limited - Unit IV, a sterile human drug manufacturer in India, received an FDA Form 483 following an inspection from April 20-28, 2017. The observations highlighted several critical deficiencies impacting Current Good Manufacturing Practices (cGMP).

Main violations included inadequate facility and equipment maintenance, such as damaged cleanroom surfaces, non-functional environmental controls, and poorly maintained vial washing equipment, posing contamination risks. Laboratory controls were significantly flawed, with a lack of assurance for reference standard performance, deficient usage protocols for USP standards, and critical laboratory balances experiencing significant vibration. Furthermore, the firm's change management system was insufficient, often classifying significant manufacturing and equipment alterations as "Normal Minor" without proper evaluation.

The FDA also noted ineffective corrective and preventive actions (CAPAs) for out-of-specification results, where proposed solutions failed to address identified root causes. Equipment design was questioned due to an obsolete, non-functional machine positioned over sterile product vials. Computer system controls for master batch records were found lacking, with uncontrolled parallel systems in use. Lastly, procedures to prevent microbiological contamination for sterile drug products were deficient, specifically with non-quantitative glove integrity testing and inadequate glove identification. The company is required to respond to these observations with comprehensive corrective measures to ensure compliance and product safety.