767957

Covidien, LP — FEI 1219930

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 9, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
North Haven, CT (United States)

Citations

IDCFRDescription
311821 CFR 820.75(a)Documentation
313221 CFR 820.120Lack of or inadequate procedures for labeling
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation
419221 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
421621 CFR 806.30Access not permitted