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1063029

Replication Medical, Inc. — FEI 3004641714

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Monmouth Junction, NJ (United States)

Facility

Other inspections at this facility

  • 811597 (NAI Fri Dec 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 671807 (VAI Wed Jul 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
333121 CFR 820.181DMR - not or inadequately maintained
369621 CFR 820.100(b)Documentation
45421 CFR 820.40(a)Document review, approval by designated individual
53721 CFR 820.70(a)Production processes