483
Teva API India Private Ltd.Teva API India Private Ltd. – FDA 483, Feb 9, 2018
Record Details
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.
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ID · e08ae228-0589-47e5-9b19-20d7923f3eaa
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