FDA Inspection 704530 — Synergy Health AST LLC
The FDA completed an inspection of Synergy Health AST LLC on January 5, 2011 in Lima, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 5, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lima, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |