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1282054

ChiRhoClin, Inc — FEI 3003194366

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Burtonsville, MD (United States)

Facility

Other inspections at this facility

  • 1190730 (VAI Thu Nov 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011966 (VAI Tue May 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798256 (NAI Fri Sep 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 774375 (OAI Tue Apr 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 585522 (VAI Tue May 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
191421 CFR 211.166(a)Lack of written stability program
195621 CFR 211.180(e)(1)Representative Number of Batches for Annual Review
202721 CFR 211.192Investigations of discrepancies, failures
240421 CFR 211.194(a)(6)Comparison of Test Results to Specifications
357021 CFR 211.100(a)Approval and review of procedures
434021 CFR 211.142Written warehousing procedures established/followed
441321 CFR 211.194(a)(8)Second person sign off