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

Source: https://www.keypedia.com/records/483/micro-typing-systems-inc/c89bf252-f372-44c6-8572-33e31e34263e

> FDA 483 for Micro Typing Systems, Inc. on November 22, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Typing Systems, Inc.
- Inspection Date: 2021-11-22
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2019-12-10](https://www.keypedia.com/records/483/micro-typing-systems-inc/99d08611-b843-48fb-b2a9-d8beddb8b4fa)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.keypedia.com/companies/micro-typing-systems-inc/3e72c0a5-173b-405a-b3d7-f6e8aac71430

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6