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965271

Chem-Tech, Ltd. — FEI 1927341

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pleasantville, IA (United States)

Facility

Other inspections at this facility

  • 1251164 (OAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749979 (VAI Wed Oct 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 658316 (VAI Thu Apr 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 613331 (VAI Fri Sep 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
138821 CFR 211.101(d)Component addition checked by 2nd person
201621 CFR 211.188(b)(4)Weights and Measures of Components Used
360321 CFR 211.160(b)Scientifically sound laboratory controls
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.