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1284440

Cosmetic Enterprises Ltd — FEI 2025292

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pacoima, CA (United States)

Facility

Other inspections at this facility

  • 1144753 (VAI Fri Jun 11 2021 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
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
202821 CFR 211.192Extent of discrepancy, failure investigations
356921 CFR 211.89Quarantine of Rejected Components et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls
362921 CFR 211.170(b)Reserve samples identified, representative, stored
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.