FDA Inspection 836829 — BTE Technologies, LLC
The FDA completed an inspection of BTE Technologies, LLC on June 5, 2013 in Hanover, 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
- June 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hanover, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3696 | 21 CFR 820.100(b) | Documentation |