# FDA 483 - Creative Testing Solutions - July 16, 2019

Source: https://www.keypedia.com/records/483/creative-testing-solutions/401b4859-ea14-4929-91e1-e6e8c402ee20

> FDA 483 for Creative Testing Solutions on July 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creative Testing Solutions
- Inspection Date: 2019-07-16
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Creative Testing Solutions, a testing laboratory in Charlotte, revealed two significant observations. The firm failed to maintain adequate processing records, specifically lacking documented investigations for invalidated test results. Additionally, blood and blood components were not tested for transfusion-transmitted infections according to manufacturer instructions, leading to invalidated reactive and indeterminate test results.

## Related Officers

- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)
- [Brian A Graves](https://www.keypedia.com/people/brian-a-graves/cee0b090-7695-4b5d-876e-2ed75f8bcfc7)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/creative-testing-solutions/9ab5662c-2a57-4700-9d19-15389fc54a23

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7