FDA Inspection 837929 — Biodex Medical Systems, Inc.
The FDA completed an inspection of Biodex Medical Systems, Inc. on June 20, 2013 in Shirley, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shirley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |