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792112

United Laboratories Manufacturing, LLC — FEI 1000220470

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dallas, TX (United States)

Facility

Other inspections at this facility

  • 1064724 (NAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034896 (VAI Thu Dec 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828668 (VAI Mon Apr 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
122721 CFR 211.67(c)Cleaning/maintenance records not kept
139521 CFR 211.103Actual vs. theoretical yields not determined
154021 CFR 211.125(a)Strict control not exercised over labeling issued
1578721 CFR 111.410(b)Packaging - issuance, use
1598421 CFR 111.123(a)(8)Quality control - finished batch, distribution
202421 CFR 211.188(b)(12)Documentation of Batch Investigations
202621 CFR 211.192Quality control unit review of records