# FDA 483 - TRS Labs Inc. - June 14, 2024

Source: https://www.keypedia.com/records/483/trs-labs-inc/ace61db2-1a3d-412c-82a0-e8f7bceee147

> FDA 483 for TRS Labs Inc. on June 14, 2024. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRS Labs Inc.
- Inspection Date: 2024-06-14
- Product Type: veterinary
- Office Name: Atlanta District Office
- Summary: During an inspection conducted from June 11-14, 2024, at TRS Labs Inc., a nonclinical laboratory located in Athens, GA, the Food and Drug Administration (FDA) issued a Form FDA 483. This document outlines observations made by the FDA investigator, indicating conditions that require attention for compliance.

The primary observation noted was the absence of adequate written standard operating procedures (SOPs) to ensure the quality and integrity of data generated in nonclinical laboratory studies. Specifically, the firm's SOP 6.12, concerning "Water Analysis and Feed Certification," was found to be deficient. It failed to specify essential chemical and biological testing requirements for animal drinking water. Furthermore, a past protocol required water that was later found unsuitable for consumption. The firm had also reduced analytical testing requirements, eliminating critical chemical analysis for water potability. Additional shortcomings included a lack of detailed water collection methods, insufficient sampling collection points, and discrepancies between the SOP and actual practice regarding who performs water sampling.

These observations highlight concerns that the facility's methods may not consistently produce reliable data for nonclinical studies. In response to the FDA 483, TRS Labs Inc. is expected to evaluate these findings and implement corrective actions to address the identified procedural deficiencies and ensure compliance with regulatory standards for data integrity.

## Related Officers

- [Deborah A. Greco](https://www.keypedia.com/people/deborah-a-greco/38e393b5-55c4-461c-a0b0-4937e0cbec37)

Company: https://www.keypedia.com/companies/trs-labs-inc/a63a7183-a33f-43eb-a8ae-c885b9205779

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