483
Apicore Pharmaceuticals Private LtdApicore Pharmaceuticals Private Ltd – FDA 483, May 5, 2023
Record Details
An FDA inspection of Apicore Pharmaceuticals Private Ltd in Vadodara, India, identified critical deficiencies in their manufacturing operations. The firm failed to adequately validate its aseptic process for sterile drug products, including issues with media fills and disinfectant efficacy studies. Additionally, routine calibration of electronic equipment was not performed according to a written program, indicating a lack of proper quality control.
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ID · a1650a38-2f55-4071-8cfb-2041f1405a8d
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