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1265449

US Specialty Formulations LLC — FEI 3010680515

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allentown, PA (United States)

Facility

Other inspections at this facility

  • 1167934 (OAI Tue Apr 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097950 (OAI Tue Jul 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023411 (OAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928445 (OAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871574 (NAI Tue Mar 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs