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1261773

Pillar5 Pharma Inc. — FEI 3000241849

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 7, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Arnprior (Canada)

Facility

Other inspections at this facility

  • 1226692 (OAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119040 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058599 (NAI Thu May 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038745 (VAI Fri Jan 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917128 (VAI Fri Feb 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
203421 CFR 211.194(d)Laboratory equipment calibration records
360321 CFR 211.160(b)Scientifically sound laboratory controls
363021 CFR 211.170(b)Drug product reserve containers
363221 CFR 211.170(b)Annual visual exams of drug products
440221 CFR 211.192Written record of investigation incomplete