FDA Inspection 603594 — A Solutions, Inc.
The FDA completed an inspection of A Solutions, Inc. on Aug 26, 2009 in Jeffersonville, IN. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Jeffersonville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |