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984885

Colonia Care Pharmacy — FEI 3012223534

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 15, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Colonia, NJ (United States)

Facility

Other inspections at this facility

  • 1147167 (OAI Mon Jul 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088095 (OAI Mon Apr 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
186821 CFR 211.94(b)Protection from external factors
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program