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1021037

Osteotech, Inc. — FEI 3002600221

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 10, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Eatontown, NJ (United States)

Facility

Other inspections at this facility

  • 1245789 (NAI Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150237 (NAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060874 (NAI Mon Jul 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925160 (NAI Wed May 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845708 (NAI Fri Aug 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1236421 CFR 1271.195(c)Monitoring-microorganisms where appropriate