Company
United StatesKronner Prototypes, Inc., Roseburg, OR – FDA Inspections
Inspection records and compliance data for Kronner Prototypes, Inc. in Roseburg, Oregon. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected April 12, 2017.
Company Profile
This profile covers Kronner Prototypes, Inc. based in Roseburg, Oregon, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected February 4, 2013. Last inspected April 12, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009807 |
| April 15, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 875081 |
| February 4, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 816972 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kronner Prototypes, Inc.
FEI Number
3018984
Address
1443 Upper Cleveland Rapids Rd, Roseburg, Oregon 97471, United States
Country
United States
ID: 67fad6bb-e3e7-48c9-bd3c-cda19ecd864e