Home / Inspections / 1220786

1220786

Seaway Pharma Inc. — FEI 3012275336

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 21, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Massena, NY (United States)

Facility

Other inspections at this facility

  • 1272511 (OAI Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1234892 (NAI Thu Jul 25 2024 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
191821 CFR 211.166(a)(2)Stability sample storage conditions described
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
362921 CFR 211.170(b)Reserve samples identified, representative, stored
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews