FDA Inspection 601020 — Sonogage Inc

Sonogage Inc — FEI 1526843

The FDA completed an inspection of Sonogage Inc on July 31, 2009 in Cleveland, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 31, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
316421 CFR 820.184(d)Acceptance records
326821 CFR 820.80(b)Incoming inspection, testing, verification
328321 CFR 820.90(a)Specific non-conforming product procedures
329921 CFR 820.100(a)(1)Procedure for analysis of data sources
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures