FDA 483 - Apozeal Pharmaceuticals Inc. - April 09, 2019
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Torrent Pharma Inc. in Levittown, PA, received an FDA Form 483 with eight observations, highlighting significant deficiencies in their quality control unit, investigation processes, and water system management. The firm failed to adequately investigate B. cepacia contamination, ensure proper cleaning validation, and maintain appropriate equipment design, leading to potential risks for distributed drug products. Several issues were repeat deficiencies, indicating persistent non-compliance.
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