FDA Inspection
Electro Medical Equipment Co IncElectro Medical Equipment Co Inc – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns Electro Medical Equipment Co Inc, with an inspection on March 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 22, 2011
- Product Type
- Devices
View Company Profile
ID · 9ebf9524-a459-45f9-a287-5dc99c85fcd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715890
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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