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1190730

ChiRhoClin, Inc — FEI 3003194366

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 3, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Burtonsville, MD (United States)

Facility

Other inspections at this facility

  • 1282054 (VAI Mon Sep 15 2025 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
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
360321 CFR 211.160(b)Scientifically sound laboratory controls
430521 CFR 211.68(b)Backup data not assured as exact and complete