FDA 483 - Red Star Contract Manufacturing, Inc. - March 13, 2025

An FDA inspection of Red Star Contract Manufacturing, Inc. in Larwill, IN, an HCT/P distributor, revealed two significant observations. The firm failed to control storage areas to prevent mix-ups and contamination, specifically lacking a standard operating procedure for HCT/P product quarantine. Additionally, recorded storage temperatures were not periodically reviewed, and temperature monitoring probes were set outside the manufacturer's required range for HCT/P bone products.