545843

CORIN MEDICAL, LTD. — FEI 3002806725

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 30, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Cirencester (United Kingdom)

Additional Details

Postmarket Audit Inspections

Citations

IDCFRDescription
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
369621 CFR 820.100(b)Documentation
421221 CFR 806.20(b)(4)Justification for not reporting
73221 CFR 803.50(a)(2)Individual Report of Malfunction