FDA Inspection 890639 — Signal Medical Corporation

Signal Medical Corporation — FEI 3002477077

The FDA completed an inspection of Signal Medical Corporation on August 11, 2014 in Marysville, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 11, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Marysville, MI (United States)

Citations

IDCFRDescription
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures