Company
United StatesSparton Medical Systems Colorado, Frederick, CO – FDA Inspections
Inspection records and compliance data for Sparton Medical Systems Colorado in Frederick, Colorado. 4 FDA inspections on record, 1 Form 483, last inspected October 19, 2018.
Company Profile
This profile covers Sparton Medical Systems Colorado based in Frederick, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 15, 2011. Last inspected October 19, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1071225 |
| April 19, 2018 | Not classified | Medical Devices & Rad Health | 1078544 |
| January 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 863121 |
| April 15, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 720075 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sparton Medical Systems Colorado
FEI Number
3008557675
Address
4300 Godding Hollow Pkwy, Frederick, Colorado 80504, United States
Country
United States
ID: fbc451cb-6c6f-4d0a-8132-733d109accf3