FDA Inspection 1050414 — Biodex Medical Systems, Inc.
The FDA completed an inspection of Biodex Medical Systems, Inc. on May 1, 2018 in Shirley, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2018
- Fiscal Year
- 2018
- 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 |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |