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896439

Triangle Compounding Pharmacy Inc — FEI 3004969894

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 22, 2014
Fiscal Year
2014
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))
  • 1017932 (OAI Thu Jul 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913701 (OAI Fri Jan 16 2015 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
145121 CFR 211.113(b)Procedures for sterile drug products
149521 CFR 211.122(a)Written procedures describing in detail
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)