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1014340

Chemolee Lab Corporation — FEI 1642813

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irving, TX (United States)

Facility

Other inspections at this facility

  • 1271501 (VAI Fri May 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119703 (NAI Mon Feb 10 2020 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
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
181021 CFR 211.160(a)Lab controls established, including changes
194221 CFR 211.180(e)Records reviewed annually
200921 CFR 211.188Prepared for each batch, include complete information
360321 CFR 211.160(b)Scientifically sound laboratory controls