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1175365

Tropical Seas, Inc. — FEI 1035794

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 15, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Holly Hill, FL (United States)

Facility

Other inspections at this facility

  • 1054156 (OAI Wed May 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950623 (VAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 765792 (VAI Mon Feb 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699491 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
192021 CFR 211.166(a)(3)Valid stability test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls