FDA Inspection 704530 — Synergy Health AST LLC
The FDA completed an inspection of Synergy Health AST LLC on Jan 5, 2011 in Lima, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Lima, OH (United States)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |