# FDA 483 - Synchrony Labs, LLC - January 17, 2025

Source: https://www.globalkeysolutions.net/records/483/synchrony-labs-llc/811b7d74-24c6-44b0-9983-e27a001bddba

> FDA 483 for Synchrony Labs, LLC on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synchrony Labs, LLC
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Synchrony Labs, LLC, a non-clinical laboratory in Durham, NC, revealed two significant observations. The firm's quality assurance unit failed to properly document and assess deviations from approved protocols, and the study director did not ensure all study-related documentation was transferred to archives. These issues indicate deficiencies in quality system oversight and record management.

## Related Documents

- [483 - 2020-02-28](https://www.globalkeysolutions.net/records/483/synchrony-labs-llc/e7080f50-6dad-4a68-b3f1-b5d448815b75)

## Related Officers

- [Betsy C. Galliher](https://www.globalkeysolutions.net/people/betsy-c-galliher/04add63c-cbcb-42f7-b634-7c2925600bef)
- [other](https://www.globalkeysolutions.net/people/erin-m-mcdowell/7f3995e6-5596-4b3a-a99b-27d49d4b890e)

Company: https://www.globalkeysolutions.net/companies/synchrony-labs-llc/85df8679-18ac-45bd-94fb-7dea464e5b33

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