FDA 483 - Viva Pharmaceutical Inc - October 25, 2024

During an FDA inspection conducted from October 21-25, 2024, Viva Pharmaceutical Inc. received a Form FDA 483 outlining significant observations related to manufacturing practices and quality control. The inspection revealed four primary areas of concern. Firstly, equipment cleaning was found inadequate, with product residues present on machinery tagged as clean, highlighting a deficiency in cleaning and preventive maintenance procedures. Secondly, the Quality Control unit demonstrated severe shortcomings in supervisory oversight of laboratory systems and data integrity. This included the lack of a formal data integrity program, instances of unreported multiple test runs for finished products, undocumented and uninvestigated interrupted chromatography sequences, and a failure to properly document software errors and their impact on data. The firm also lacked a standardized naming system for electronic test data. Thirdly, investigations into out-of-specification results, deviations, and non-conformances were frequently inadequate. Corrective actions often involved simple retesting without sufficient root cause analysis, resulting in incomplete and ineffective corrective and preventive action plans. Finally, facility maintenance was substandard, with observed cracks and damage on production room flooring and a lack of adequate preventive maintenance for room conditions. These observations indicate a need for Viva Pharmaceutical Inc. to implement robust corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing.