Micro Typing Systems, Inc.November 22, 2021

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Micro Typing Systems, Inc.

Record Details

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.

Company: Micro Typing Systems, Inc.
Inspection Date: November 22, 2021
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
People: Laurel A. Beer
Susan M. Jackson (investigator)

Open in Dashboard

ID · c89bf252-f372-44c6-8572-33e31e34263e