FDA Inspection 801687 — BSN Medical, Inc.
The FDA completed an inspection of BSN Medical, Inc. on October 10, 2012 in Hickory, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 10, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hickory, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |