Kreative Organics Private Limited – FDA 483, Feb 7, 2020
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.
ID · f59c7849-6886-4ec6-8200-40281b635fbe
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