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1272511

Seaway Pharma Inc. — FEI 3012275336

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Massena, NY (United States)

Facility

Other inspections at this facility

  • 1234892 (NAI Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1220786 (OAI Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151771 (OAI Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097845 (VAI Thu Jul 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075781 (OAI Mon Dec 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation