FDA Inspection 918132 — Biodex Medical Systems, Inc.
The FDA completed an inspection of Biodex Medical Systems, Inc. on March 17, 2015 in Shirley, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shirley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 512 | 21 CFR 820.65 | Traceability Lack of or inadequate {see also 820.120(e)} |
| 537 | 21 CFR 820.70(a) | Production processes |