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1219446

Richard E. Colgin, Inc — FEI 1610391

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 21, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dallas, TX (United States)

Facility

Other inspections at this facility

  • 1307754 (NAI Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953974 (VAI Tue Jan 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 657667 (VAI Wed Apr 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
139521 CFR 211.103Actual vs. theoretical yields not determined
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution