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1264362

Cosmetic Essence, LLC. — FEI 1117550

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Roanoke, VA (United States)

Facility

Other inspections at this facility

  • 1119390 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933941 (VAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 745485 (VAI Mon Sep 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
117721 CFR 211.63Equipment Design, Size and Location
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
356921 CFR 211.89Quarantine of Rejected Components et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
441321 CFR 211.194(a)(8)Second person sign off
457621 CFR 211.192No written record of investigation