# FDA 483 - Stephen G. Thein, Ph.D. - April 25, 2025

Source: https://www.keypedia.com/records/483/stephen-g-thein-phd/ebf5447b-fa2c-4b23-ba5c-e9211916f398

> FDA 483 for Stephen G. Thein, Ph.D. on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stephen G. Thein, Ph.D.
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Pacific Research Network (PRN) in San Diego, a clinical investigator, was cited for failing to conduct an investigation in accordance with its investigational plan. Specifically, participants who tested positive for cannabinoids were allowed to continue in a study without termination or proper reporting. Additionally, the firm implemented changes in research activity without prior Institutional Review Board (IRB) approval.

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Company: https://www.keypedia.com/companies/stephen-g-thein-phd/2a25ad58-adfe-4fd2-9977-ec4ad8a26755

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b