FDA Inspection 1199302 — Biodex Medical Systems, Inc.
The FDA completed an inspection of Biodex Medical Systems, Inc. on February 10, 2023 in Shirley, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 10, 2023
- Fiscal Year
- 2023
- 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 |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |