FDA 483 - Micro Typing Systems, Inc. - November 22, 2021

An FDA inspection of Micro Typing Systems, Inc. in Pompano Beach, FL, an IVD manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive actions for non-conformance events related to quality control testing. Additionally, document control procedures were not properly established, leading to uncontrolled master production records and blank forms with unrestricted access.