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942800

INCELL Corporation LLC — FEI 3004107906

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 1, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Antonio, TX (United States)

Facility

Other inspections at this facility

  • 1219086 (OAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069229 (NAI Thu Sep 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 860185 (NAI Thu Dec 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
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
18009FDCA 503B(a)(10)Container label, outsourcer facility