FDA 483 - Stat Medical Devices, Inc. - November 07, 2022

Stat Medical Devices, Inc. in North Miami Beach, FL, received a Form FDA 483 following an inspection from November 3-7, 2022. The inspection revealed significant deficiencies in the firm's purchasing control procedures, including inadequate supplier audit frequencies and issues with contract sterilizer qualification. Additionally, the firm failed to ensure adequate training for its Quality Manager regarding Quality System Regulations.