FDA 483 - Auriga Research Private Limited - July 22, 2022

Auriga Research Private Limited, a contract testing facility in Bengaluru, India, received a Form 483 for significant deficiencies in its quality control unit and equipment design. Observations included inadequate written procedures, poor documentation practices, and lack of verification for critical equipment settings, impacting the integrity of microbial limit testing for drug substance samples. These issues indicate a moderate level of non-compliance with good manufacturing practices.