FDA Inspection 857835 — The Standing Company

The Standing Company — FEI 3007494904

The FDA completed an inspection of The Standing Company on December 6, 2013 in Saginaw, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 6, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Saginaw, MI (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate