Company
United StatesSparton Medical, Strongsville, OH – FDA Inspections
Inspection records and compliance data for Sparton Medical in Strongsville, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected August 24, 2018.
Company Profile
This profile covers Sparton Medical based in Strongsville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 2, 2009. Last inspected August 24, 2018.
Most cited issue areas
- Equipment control activity documentation1 inspection
- Lack of Written MDR Procedures1 inspection
- Supplier oversight1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 24, 2018 | Not classified | Medical Devices & Rad Health | 1142241 |
| April 27, 2017 | Not classified | Medical Devices & Rad Health | 1034623 |
| April 12, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 776779 |
| February 2, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 557942 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sparton Medical
FEI Number
3004099094
Address
22740 Lunn Rd, Strongsville, Ohio 44149, United States
Country
United States
ID: dd9875a8-267b-4aaa-8a9d-5034e23a3bc0