FDA Inspection 1017867 — Andersen Products, Inc.
The FDA completed an inspection of Andersen Products, Inc. on July 14, 2017 in Haw River, NC. 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
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Haw River, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |