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742145

Chemolee Lab Corporation — FEI 1642813

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 1, 2011
Fiscal Year
2011
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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
181021 CFR 211.160(a)Lab controls established, including changes
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
202621 CFR 211.192Quality control unit review of records
359221 CFR 211.110(c)In-process materials characteristics testing
360321 CFR 211.160(b)Scientifically sound laboratory controls
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
440621 CFR 211.194(a)(2)Suitability of testing methods verified