Home / Inspections / 1097950

1097950

US Specialty Formulations LLC — FEI 3010680515

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 23, 2019
Fiscal Year
2019
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))
  • 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
113321 CFR 211.25(a)GMP Training Frequency
115921 CFR 211.28(a)Clothing appropriate for duties performed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
145421 CFR 211.115(a)Reprocessing procedures not written or followed
18008FDCA 503B(a)(10)Drug product label, outsourcer facility
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
189121 CFR 211.165(f)Failing drug products not rejected
435521 CFR 211.165(c)Sampling and testing plans not followed
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.