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1017462

SKNV — FEI 3012384835

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 26, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pompano Beach, FL (United States)

Facility

Other inspections at this facility

  • 1263272 (VAI Thu Mar 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229212 (VAI Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065810 (VAI Mon Sep 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986127 (OAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
162621 CFR 211.130Procedures are written, and followed
18008FDCA 503B(a)(10)Drug product label, outsourcer facility