Company
United StatesProtek Medical Products Inc, Coralville, IA – FDA Inspections
Inspection records and compliance data for Protek Medical Products Inc in Coralville, Iowa. 4 FDA inspections on record, 1 Form 483, last inspected August 08, 2019.
Company Profile
This profile covers Protek Medical Products Inc based in Coralville, Iowa, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected July 21, 2009. Last inspected August 8, 2019.
Most cited issue areas
- Implementing Personnel Procedures, Health, Cleanliness.1 inspection
- Lack of System for Timely Submission of Reports1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1099061 |
| October 6, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 989313 |
| January 21, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 863555 |
| July 21, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 598379 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Protek Medical Products Inc
FEI Number
3001701594
Address
4125 Westcor Ct, Coralville, Iowa 52241, United States
Country
United States
ID: f5424d95-6e68-44ee-b658-d8a1b59b323f