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1063577

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

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 28, 2018
Fiscal Year
2018
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))
  • 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))
  • 789181 (OAI Wed Jul 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
192621 CFR 211.166(b)Adequate number of batches on stability
356721 CFR 211.84(d)(2)Component identification test
358521 CFR 211.110(a)Control procedures to monitor and validate performance
362921 CFR 211.170(b)Reserve samples identified, representative, stored
436421 CFR 211.176Failing to test for penicillin cross-contamination