FDA Inspection 557503 — ADDTO, INC.
The FDA completed an inspection of ADDTO, INC. on Jan 16, 2009 in Elgin, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 16, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |