# FDA 483 - Mark Two Engineering Inc. - August 06, 2019

Source: https://www.keypedia.com/records/483/mark-two-engineering-inc/4affc770-32a8-4afe-8fff-7c025a4906d4

> FDA 483 for Mark Two Engineering Inc. on August 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Two Engineering Inc.
- Inspection Date: 2019-08-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Mark Two Engineering Inc. in Miami Lakes, FL, a medical device manufacturer, revealed significant deficiencies across its quality management system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, control of nonconforming products, process validation, and complaint handling. These issues indicate a systemic breakdown in maintaining compliance with quality system requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/mark-two-engineering-inc/2a8ce9be-29e0-4a05-a132-d654756b3fca

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