1054538

ITG-Medev, Inc. — FEI 1000307251

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 6, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
San Francisco, CA (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
341521 CFR 820.22Quality Audit/Reaudit - conducted
342621 CFR 820.50(a)(1)Documented evaluation
343421 CFR 820.75(c)Documentation - review in response to changes or deviations
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency