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1054156

Tropical Seas, Inc. — FEI 1035794

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 30, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
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))
  • 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
358121 CFR 211.101(d)Verification of component addition
358321 CFR 211.110(a)Written in-process control procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
438021 CFR 211.198(b)(3)Determination not to conduct investigation of complaint
440921 CFR 211.194(a)(4)Data secured in course of each test