FDA Inspection 761505 — Biodex Medical Systems, Inc.
The FDA completed an inspection of Biodex Medical Systems, Inc. on December 22, 2011 in Shirley, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shirley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |
| 650 | 21 CFR 803.18(e) | Results of evaluation not in mfr's MDR file |