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1251234

United Laboratories Manufacturing, LLC — FEI 3006056935

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carrollton, TX (United States)

Facility

Other inspections at this facility

  • 1255830 (NAI Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208568 (NAI Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047444 (VAI Mon Apr 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987414 (VAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 796232 (VAI Thu Aug 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
145021 CFR 211.113(a)Procedures for non-sterile drug products
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
189121 CFR 211.165(f)Failing drug products not rejected
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings