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1246936

Pine Pharmaceuticals, LLC — FEI 3010943533

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 30, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tonawanda, NY (United States)

Facility

Other inspections at this facility

  • 1141929 (OAI Fri May 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049641 (VAI Thu Apr 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945292 (OAI Fri Oct 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900138 (NAI Fri Oct 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
139521 CFR 211.103Actual vs. theoretical yields not determined
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures