Teva API India Ltd- MalanpurApril 16, 2019

FDA 483 - Teva API India Ltd- Malanpur - April 16, 2019

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An FDA inspection of Teva API India Pvt. Ltd. revealed significant deficiencies across its operations. The firm failed to conduct adequate risk assessments for impurities in Key Starting Materials and lacked properly validated cleaning processes for non-dedicated equipment. Additionally, the Quality Unit did not consistently follow its own procedures, and production equipment was stored in conditions that risked contamination.

Company: Teva API India Ltd- Malanpur
Inspection Date: April 16, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Anita Tiwari
Rajiv R. Srivastava (Consumer Safety Officer)
Dipesh K. Shah

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