FDA Inspection 559035 — Futrex Tech, Inc.
The FDA completed an inspection of Futrex Tech, Inc. on January 23, 2009 in Hagerstown, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hagerstown, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |