# FDA 483 - Florida Suncare Testing Inc. - July 24, 2025

Source: https://www.keypedia.com/records/483/florida-suncare-testing-inc/39b39958-1a44-4cae-adea-3fd222fef365

> FDA 483 for Florida Suncare Testing Inc. on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Florida Suncare Testing Inc.
- Inspection Date: 2025-07-24
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Florida Suncare Testing Inc., a contract testing laboratory in Bunnell, FL, was cited for significant deficiencies in its quality control unit and data integrity practices. The inspection revealed a lack of appropriate controls over computer systems, including HPLC data, and widespread failures in quality unit responsibilities, such as inadequate investigations, method validation, and personnel training. These issues indicate a systemic breakdown in the firm's quality management system.

## Related Officers

- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/florida-suncare-testing-inc/e171053e-860e-4431-b75d-a7ee23029248

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