483
Sandoz Private LimitedSandoz Private Limited – FDA 483, Jan 22, 2024
Record Details
Sandoz Private Limited in Hyderabad, India, received a Form 483 with three observations related to significant data integrity and quality system deficiencies. The firm failed to thoroughly investigate lost chromatographic data and lacked adequate oversight of GMP document management, including instances of document destruction. Additionally, the employee training program was found to be deficient, not ensuring employees' familiarity with CGMP requirements.
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ID · a4c9e074-5b3a-41fc-a03e-155f1c8c0197
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