# FDA 483 - Certified Laboratories LLC - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/certified-laboratories-llc/ffb75c36-fa5a-4d7f-b663-dcb78c87e3b1

> FDA 483 for Certified Laboratories LLC on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Certified Laboratories LLC
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Certified Laboratories LLC in Carrollton, TX, a contract testing laboratory, was cited for deficient laboratory records during an FDA inspection. The firm failed to maintain complete data for testing, specifically regarding multiple instances of aborted test runs on laboratory equipment without proper justification or documentation. Furthermore, the firm lacked established written procedures for authorizing, reporting, and documenting such aborted runs, raising concerns about data integrity and quality control.

## Related Documents

- [483 - 2022-05-20](https://www.globalkeysolutions.net/records/483/certified-laboratories-llc/02ba5b9f-bc47-4815-aef5-fe65931e4825)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)
- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)

Company: https://www.globalkeysolutions.net/companies/certified-laboratories-llc/d411cf88-a1cd-4155-a3b8-e68ead073add

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9