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1219086

INCELL Corporation LLC — FEI 3004107906

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 29, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
San Antonio, TX (United States)

Facility

Other inspections at this facility

  • 1069229 (NAI Thu Sep 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942800 (OAI Tue Sep 01 2015 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
145121 CFR 211.113(b)Procedures for sterile drug products
176721 CFR 211.137(a)Expiration date lacking
188321 CFR 211.165(a)Testing and release for distribution