822887

Premier Heart, LLC — FEI 3003289183

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 15, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Port Washington, NY (United States)

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
319921 CFR 820.40(a)Document review, approval documentation