FDA Inspection 766684 — Advanced Medical Instruments, Inc.
The FDA completed an inspection of Advanced Medical Instruments, Inc. on Feb 24, 2012 in Broken Arrow, OK. 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
- Feb 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Broken Arrow, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3409 | 21 CFR 820.200(d) | Service reports |