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728478

Ortho Development Corporation — FEI 1000143502

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 3, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Draper, UT (United States)

Facility

Other inspections at this facility

  • 1149215 (NAI Mon Jul 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990045 (NAI Tue Oct 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927114 (NAI Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858180 (NAI Tue Dec 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction