FDA Inspection
Epley Medical, Inc. dba: VesticonEpley Medical, Inc. dba: Vesticon – FDA Inspection, Dec 15, 2009
Record Details
This FDA Inspection record concerns Epley Medical, Inc. dba: Vesticon, with an inspection on December 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 15, 2009
- Product Type
- Devices
View Company Profile
ID · ed82aee2-e018-4d50-91f3-3c4e4ef80300
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635325
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(e)Quality System Procedures
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