FDA Inspection
Sparton MedicalSparton Medical – FDA Inspection, Feb 2, 2009
Record Details
This FDA Inspection record concerns Sparton Medical, with an inspection on February 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sparton Medical
- Inspection Date
- February 2, 2009
- Product Type
- Devices
View Company Profile
ID · 7dc892b6-8435-4e6e-a939-e0d7fd645882
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 557942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sparton Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2018 | Not classified | Cincinnati District Office | |
| April 27, 2017 | Not classified | Cincinnati District Office | |
| April 12, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sparton Medical
- FDA Inspection 1142241 - 2018-08-24
- FDA Inspection 1034623 - 2017-04-27
- FDA Inspection 776779 - 2012-04-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.