FDA Inspection 863555 — Protek Medical Products Inc
The FDA completed an inspection of Protek Medical Products Inc on January 21, 2014 in Coralville, IA. 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
- January 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coralville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |