FDA Inspection 814222 — Vanguard EMS, Inc.

Vanguard EMS, Inc. — FEI 3004363082

The FDA completed an inspection of Vanguard EMS, Inc. on January 15, 2013 in Beaverton, OR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
January 15, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Beaverton, OR (United States)

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures