FDA Inspection 1099061 — Protek Medical Products Inc
The FDA completed an inspection of Protek Medical Products Inc on August 8, 2019 in Coralville, IA. 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
- August 8, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Coralville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |