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843220

Chemolee Lab Corporation — FEI 1642813

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2013
Fiscal Year
2013
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))
  • 742145 (OAI Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145021 CFR 211.113(a)Procedures for non-sterile drug products
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy