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1031525

Safetec Of America, Inc. — FEI 1000159898

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Buffalo, NY (United States)

Facility

Other inspections at this facility

  • 1254211 (VAI Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119915 (VAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947302 (VAI Fri Oct 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 794760 (VAI Wed Aug 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733807 (VAI Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
192621 CFR 211.166(b)Adequate number of batches on stability
361221 CFR 211.160(b)(3)Sampling/testing of drug products
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
440621 CFR 211.194(a)(2)Suitability of testing methods verified