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800164

Elba, Inc. — FEI 1000115351

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 27, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Troy, MI (United States)

Facility

Other inspections at this facility

  • 1269782 (OAI Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1130439 (NAI Tue Sep 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029307 (VAI Thu Oct 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866873 (VAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727271 (OAI Wed Jun 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
192021 CFR 211.166(a)(3)Valid stability test methods
203121 CFR 211.194(a)Complete test data included in records
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440621 CFR 211.194(a)(2)Suitability of testing methods verified