# FDA 483 - Product Safety Labs - July 24, 2025

Source: https://www.keypedia.com/records/483/product-safety-labs/f6c96d7b-dc31-45ba-aeae-a1c68a848df4

> FDA 483 for Product Safety Labs on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Product Safety Labs
- Inspection Date: 2025-07-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: During an inspection conducted from July 21-24, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Product Safety Labs, a nonclinical laboratory located in Dayton, NJ. The inspection revealed two significant observations indicating a need for improved adherence to established procedures and facility controls. The primary issue involved inadequate management authorization for changes to standard operating procedures (SOPs). Specifically, the SOP for "Transfer of Archived Materials" was not followed, leading to several deficiencies. These included wet tissues for two studies not being properly signed out, the inability of the archivist to locate documentation for tissue sign-out, lack of archivist access to sponsor agreements, and the discovery of unattended wet tissues in an unsecure laboratory. The second observation highlighted concerns with the facility's design and maintenance, specifically regarding its ability to prevent adverse effects on studies. Damaged contamination control floor mats, which had exceeded their manufacturer-specified lifespan, were observed throughout the facility. Furthermore, Product Safety Labs lacked a written procedure for the maintenance of these critical contamination control measures. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, require Product Safety Labs to promptly address the identified conditions and practices. While the 483 form itself does not mandate specific actions, the firm is expected to respond to the FDA by detailing the corrective actions it has taken or plans to implement to rectify these compliance issues and ensure the integrity of their nonclinical studies.

## Related Officers

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

Company: https://www.keypedia.com/companies/product-safety-labs/3af10f6f-e3d4-4054-95d3-06bed1324f45

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