# FDA 483 - Tarmac Products, Inc. - September 27, 2019

Source: https://www.globalkeysolutions.net/records/483/tarmac-products-inc/b6c8f7d7-3760-4d8e-a5a6-549d584aa5a9

> FDA 483 for Tarmac Products, Inc. on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tarmac Products, Inc.
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Tarmac Products, Inc. in Miami Gardens, FL, a manufacturer of OTC drug and medical device products, received a Form FDA 483 with 17 observations. The inspection revealed significant deficiencies in process validation, laboratory controls, data integrity, stability testing, CAPA procedures, equipment qualification and calibration, complaint handling, design control, quality audits, organizational structure, and supplier controls. Many of these issues, particularly regarding laboratory records, stability testing, and quality unit procedures, were repeat observations from previous inspections, indicating a systemic failure to implement effective corrective actions.

## Related Documents

- [WARNING_LETTER - 2019-09-27](https://www.globalkeysolutions.net/records/warning_letter/tarmac-products-inc/11b8412d-4952-4f4d-ab6c-cee98cfbf7c6)
- [483 - 2022-07-22](https://www.globalkeysolutions.net/records/483/tarmac-products-inc/4c6888b3-75cb-4f56-bbf0-77139b882a88)
- [483 - 2025-11-04](https://www.globalkeysolutions.net/records/483/tarmac-products-inc/5dd51685-e113-4734-99c6-a253a7c49dff)

## Related Officers

- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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

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