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950623

Tropical Seas, Inc. — FEI 1035794

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 19, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Holly Hill, FL (United States)

Facility

Other inspections at this facility

  • 1175365 (OAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054156 (OAI Wed May 30 2018 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
113421 CFR 211.25(b)Supervisor Training/Education/Experience
136121 CFR 211.100(a)Absence of Written Procedures
192721 CFR 211.166(b)Accelerated stability studies
202721 CFR 211.192Investigations of discrepancies, failures
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit
439121 CFR 211.180(e)(2)Items to cover on annual reviews