# FDA 483 - TRS Labs Inc. - April 22, 2022

Source: https://www.keypedia.com/records/483/trs-labs-inc/5402f8f3-1520-4d04-b20e-92ecaf9dcb4f

> FDA 483 for TRS Labs Inc. on April 22, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRS Labs Inc.
- Inspection Date: 2022-04-22
- Product Type: other
- Office Name: Atlanta District Office
- Summary: This FDA Form 483 report details observations made at TRS Labs Inc., a nonclinical laboratory in Athens, GA. The inspection revealed significant deficiencies in the firm's quality assurance unit, standard operating procedures, and record-keeping practices. Issues include failure to follow and review SOPs, lack of proper documentation for equipment maintenance and water testing, and inadequate oversight by the quality assurance unit.

## Related Documents

- [483 - 2024-06-14](https://www.keypedia.com/records/483/trs-labs-inc/24ed777c-2fe2-4cec-8aaf-be181f86a739)

## Related Officers

- [Vanessa E. Coulter](https://www.keypedia.com/people/vanessa-e-coulter/add8407c-0df8-43ed-9f5a-8063880ce638)
- [Hugh M. Mcclure](https://www.keypedia.com/people/hugh-m-mcclure/e69b7562-8fb5-4b7d-a506-a9bc0f0e9e43)

Company: https://www.keypedia.com/companies/trs-labs-inc/d8961d49-a184-4b46-8a03-30714df5a082

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