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

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.