# FDA 483 - Micro Typing Systems, Inc. - December 10, 2019

Source: https://www.keypedia.com/records/483/micro-typing-systems-inc/99d08611-b843-48fb-b2a9-d8beddb8b4fa

> FDA 483 for Micro Typing Systems, Inc. on December 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Typing Systems, Inc.
- Inspection Date: 2019-12-10
- Product Type: device
- 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 across four observations. The firm failed to adequately establish corrective and preventive action procedures, maintain proper change control records, control non-conforming products with defined timelines, and ensure document control for electronic data protection.

## Related Documents

- [483 - 2021-11-22](https://www.keypedia.com/records/483/micro-typing-systems-inc/c89bf252-f372-44c6-8572-33e31e34263e)

## Related Officers

- [Sharmila Shrestha](https://www.keypedia.com/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Meihong Liu](https://www.keypedia.com/people/meihong-liu/6fa7f71f-7c5c-4602-9fed-e627828c5670)

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