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1031836

Cosmetics & Cleaners International LLC — FEI 3009878984

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 21, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
High Point, NC (United States)

Facility

Other inspections at this facility

  • 1200079 (NAI Thu Mar 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118137 (NAI Wed Feb 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118745 (NAI Thu Feb 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
119421 CFR 211.42(c)Defined areas of adequate size for operations
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
202621 CFR 211.192Quality control unit review of records
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.