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1095091

LifeCell Corporation — FEI 1000306051

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 14, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Branchburg, NJ (United States)

Facility

Other inspections at this facility

  • 1230349 (NAI Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120984 (NAI Thu Feb 20 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028651 (NAI Wed Sep 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023275 (NAI Fri Aug 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980020 (NAI Tue Jun 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation