# FDA 483 - Synergy Health AST, LLC - June 06, 2025

Source: https://www.globalkeysolutions.net/records/483/synergy-health-ast-llc/812da5e4-fdc6-4467-bf6f-c6623c46a95e

> FDA 483 for Synergy Health AST, LLC on June 06, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergy Health AST, LLC
- Inspection Date: 2025-06-06
- Product Type: other
- Office Name: San Francisco District Office
- Summary: During an inspection from June 3-6, 2025, the FDA cited Synergy Health AST, LLC in Petaluma, CA, for failing to thoroughly review unexplained discrepancies. Specifically, the firm did not reevaluate an irradiated drug product lot after a significant temperature excursion in storage, leading to its distribution without proper disposition in records. This indicates a critical lapse in quality control and batch release procedures.

## Related Officers

- [Crystal Monroy](https://www.globalkeysolutions.net/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.globalkeysolutions.net/companies/synergy-health-ast-llc/8aea6ef0-2a40-415f-9b44-a3fb0333ed89

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df