FDA Inspection 803264 — Superstat Corporation

Superstat Corporation — FEI 3001452136

The FDA completed an inspection of Superstat Corporation on October 15, 2012 in Rancho Dominguez, CA. 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
October 15, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Rancho Dominguez, CA (United States)

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
54621 CFR 820.75(a)Lack of or inadequate process validation