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1144753

Cosmetic Enterprises Ltd — FEI 2025292

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 11, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pacoima, CA (United States)

Facility

Other inspections at this facility

  • 1284440 (VAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981328 (NAI Tue Aug 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773368 (NAI Mon Mar 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723725 (NAI Mon May 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 542822 (NAI Wed Oct 08 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
145421 CFR 211.115(a)Reprocessing procedures not written or followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test