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1023411

US Specialty Formulations LLC — FEI 3010680515

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 29, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allentown, PA (United States)

Facility

Other inspections at this facility

  • 1265449 (VAI Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 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
115921 CFR 211.28(a)Clothing appropriate for duties performed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
143521 CFR 211.42(c)(10)(v)Cleaning System
18009FDCA 503B(a)(10)Container label, outsourcer facility
188321 CFR 211.165(a)Testing and release for distribution
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records