FDA Inspection 636500 — Northgate Technologies, Inc.
The FDA completed an inspection of Northgate Technologies, Inc. on November 13, 2009 in Elgin, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |