FDA 483 - Vivex Biologics, Inc. - July 06, 2017

Osiris Biomedical, Inc. in Miami, FL, an HCTP manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of validation for their disinfection process, inadequate investigations into numerous positive post-processing cultures, and processing HCT/Ps without proper disinfection. Additionally, the firm failed to maintain equipment cleanliness, with rusted carts found in clean processing rooms.