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1271501

Chemolee Lab Corporation — FEI 1642813

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 30, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irving, TX (United States)

Facility

Other inspections at this facility

  • 1119703 (NAI Mon Feb 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014340 (VAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916451 (OAI Fri Feb 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843220 (VAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 742145 (OAI Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122721 CFR 211.67(c)Cleaning/maintenance records not kept
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
180221 CFR 211.84(b)Representative Samples
188321 CFR 211.165(a)Testing and release for distribution
194221 CFR 211.180(e)Records reviewed annually
360321 CFR 211.160(b)Scientifically sound laboratory controls
437921 CFR 211.188(b)(1)Dates not included for each significant step