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1269782

Elba, Inc. — FEI 1000115351

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Troy, MI (United States)

Facility

Other inspections at this facility

  • 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))
  • 800164 (OAI Thu Sep 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727271 (OAI Wed Jun 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products