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1141929

Pine Pharmaceuticals, LLC — FEI 3010943533

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 14, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tonawanda, NY (United States)

Facility

Other inspections at this facility

  • 1246936 (OAI Mon Sep 30 2024 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
109821 CFR 211.22(c)Approve or reject procedures or specs
126121 CFR 211.68(a)Written calibration / inspection records not kept
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls