FDA 483 - Teva API India Private Ltd. - February 09, 2018

An FDA inspection of Teva API India Pvt. Ltd. in Gajraula, India, a non-sterile API manufacturer, identified critical deficiencies in quality control. The firm failed to store drug substances under appropriate temperature conditions and lacked a proper pest control program. Additionally, inadequate investigations into manufacturing deviations and poorly designed equipment hindering cleaning were noted, indicating a risk to the identity, strength, quality, and purity of drug substances.