FDA Inspection
Electra Medical CorporationElectra Medical Corporation – FDA Inspection, Nov 7, 2008
Record Details
This FDA Inspection record concerns Electra Medical Corporation, with an inspection on November 7, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Electra Medical Corporation
- Inspection Date
- November 7, 2008
- Product Type
- Devices
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ID · 30aeb0fa-e371-417d-95fe-004a8d51b884
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547931
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)General
- 21 CFR 803.17Lack of Written MDR Procedures
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