FDA Inspection 613087 — Multi-Med, Inc.
The FDA completed an inspection of Multi-Med, Inc. on September 11, 2009 in Keene, NH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 11, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Keene, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |