FDA Inspection 589973 — Alltech Medical Systems America Inc
The FDA completed an inspection of Alltech Medical Systems America Inc on June 17, 2009 in Solon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |