FDA 483 - Tanvex BioPharma USA, Inc

The FDA inspection of Tanvex BioPharma USA, Inc. in San Diego revealed significant deficiencies in their bulk drug substance and drug product manufacturing. Key issues include inadequate quality control unit oversight, particularly concerning manual integration of chromatographic data and data integrity, and widespread problems with aseptic processing controls, equipment qualification, environmental monitoring, and written procedures. These findings indicate a systemic lack of adherence to cGMP requirements, posing potential risks to product quality and sterility.