483
Synergy Health AST, LLCFDA 483 - Synergy Health AST, LLC - June 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Person
Open in Dashboard
ID · 812da5e4-fdc6-4467-bf6f-c6623c46a95e