FDA Inspection 935001 — Amvex Corporation
The FDA completed an inspection of Amvex Corporation on Jun 18, 2015 in Richmond Hill. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richmond Hill (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |