FDA Inspection 554460 — Addition Technology Inc
The FDA completed an inspection of Addition Technology Inc on Dec 15, 2008 in Lombard, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lombard, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3291 | 21 CFR 820.100(b) | Procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |