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749979

Chem-Tech, Ltd. — FEI 1927341

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 19, 2011
Fiscal Year
2012
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))
  • 965271 (VAI Fri Dec 11 2015 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
154021 CFR 211.125(a)Strict control not exercised over labeling issued
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
191821 CFR 211.166(a)(2)Stability sample storage conditions described
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls