FDA 483 - Kreative Organics Private Limited - February 07, 2020
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An FDA inspection of Innovative Organics Private Limited in Hyderabad, India, revealed significant quality control deficiencies. The firm released an API batch potentially contaminated with glass particulates to the American market and failed to conduct thorough investigations into deviations and out-of-specification results. Additionally, the Quality Control Unit maintained incomplete procedures, lacked proper system access controls, and had issues with equipment calibration and stability studies.
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