Teva API India Private Ltd.February 9, 2018

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

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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.

Company: Teva API India Private Ltd.
Inspection Date: February 9, 2018
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Kellia N. Hicks (Investigator)

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