FDA Inspection 781196 — Haven Innovation, Inc.
The FDA completed an inspection of Haven Innovation, Inc. on May 2, 2012 in Grand Haven, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Grand Haven, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |