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789181

RTI Surgical, Inc. dba RTI Biologics, Inc. — FEI 3002719998

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 11, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Alachua, FL (United States)

Facility

Other inspections at this facility

  • 1198983 (NAI Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084437 (NAI Thu Mar 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063577 (OAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984189 (NAI Fri Jun 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847712 (NAI Tue Sep 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1232021 CFR 1271.160(b)(3)Actions verified, short and long term solutions
1232321 CFR 1271.160(b)(5)Monitoring systems
1235621 CFR 1271.195(a)Adequate control, proper conditions
1235721 CFR 1271.195(a)(1)Temperature and humidity controls
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1236221 CFR 1271.195(b)Corrective actions
1236321 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
1239821 CFR 1271.230(a)Validation & approval--established procedures