FDA 483 - Scientific Supplies & Technology, Inc. - November 09, 2023

Scientific Supplies & Technology, Inc. in Miami, FL, a manufacturer of clinical chemical reagents, was inspected and cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for complaint handling, corrective and preventive actions, and Medical Device Reporting. Additionally, the firm failed to maintain device history records for its Class 2 devices.