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1017932

Triangle Compounding Pharmacy Inc — FEI 3004969894

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 13, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cary, NC (United States)

Facility

Other inspections at this facility

  • 1088641 (VAI Thu Apr 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913701 (OAI Fri Jan 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896439 (OAI Mon Sep 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821119 (OAI Fri Mar 01 2013 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
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
163021 CFR 211.130(b)Unlabeled filled containers controls
185121 CFR 211.84(e)Rejecting When Specifications Not Met
186821 CFR 211.94(b)Protection from external factors
188321 CFR 211.165(a)Testing and release for distribution
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures