# FDA 483 - Tarmac Products, Inc. - November 04, 2025

Source: https://www.keypedia.com/records/483/tarmac-products-inc/5dd51685-e113-4734-99c6-a253a7c49dff

> FDA 483 for Tarmac Products, Inc. on November 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tarmac Products, Inc.
- Inspection Date: 2025-11-04
- Product Type: device
- Office Name: Florida District Office
- Summary: Tarmac Products, Inc. in Miami Gardens, FL, a contract manufacturer of medical devices, was cited for multiple significant quality system deficiencies during an FDA inspection. Key issues include inadequate pest control leading to potential product contamination, failures in medical device reporting, lack of management reviews and quality audits, and non-compliance with Unique Device Identifier (UDI) requirements. Many of these deficiencies were repeat observations from previous inspections, indicating systemic problems.

## Related Documents

- [483 - 2019-09-27](https://www.keypedia.com/records/483/tarmac-products-inc/b6c8f7d7-3760-4d8e-a5a6-549d584aa5a9)
- [WARNING_LETTER - 2019-09-27](https://www.keypedia.com/records/warning_letter/tarmac-products-inc/11b8412d-4952-4f4d-ab6c-cee98cfbf7c6)
- [483 - 2022-07-22](https://www.keypedia.com/records/483/tarmac-products-inc/4c6888b3-75cb-4f56-bbf0-77139b882a88)

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/tarmac-products-inc/faf7213b-98c9-4af3-8a6a-81115857e208

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9