FDA Inspection 998178 — Amico Beds Corporation
The FDA completed an inspection of Amico Beds Corporation on June 23, 2016 in Richmond Hill. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 23, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richmond Hill (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3837 | 21 CFR 820.25(b) | Training records |