# FDA 483 - Creative Testing Solutions - August 29, 2025

Source: https://www.keypedia.com/records/483/creative-testing-solutions/1b946a26-ef8e-41e5-9ed9-e2896aaf8644

> FDA 483 for Creative Testing Solutions on August 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creative Testing Solutions
- Inspection Date: 2025-08-29
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Creative Testing Solutions in Tempe, AZ, a testing laboratory, received a Form 483 with two observations. The inspection revealed failures to follow manufacturer's instructions for communicable disease agent testing, specifically concerning reagent reservoir use and cleaning. Additionally, the firm failed to thoroughly investigate and document unexplained discrepancies, including issues with quality control lot numbers and reference ranges.

## Related Documents

- [483 - 2025-08-29](https://www.keypedia.com/records/483/creative-testing-solutions/cc084e4f-19c1-4ef1-a9f2-a53b81e1c8db)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)
- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

Company: https://www.keypedia.com/companies/creative-testing-solutions/4a312d2f-68a4-4a32-aec9-e8bf96d81b9a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face