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1263272

SKNV — FEI 3012384835

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pompano Beach, FL (United States)

Facility

Other inspections at this facility

  • 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))
  • 1017462 (VAI Mon Jun 26 2017 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
202721 CFR 211.192Investigations of discrepancies, failures
22733FDCA 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
22789FDCA 503B(a)(10)(B)Drug product container, fails to include