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1240591

Denison Pharmaceuticals, LLC — FEI 1210580

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 29, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lincoln, RI (United States)

Facility

Other inspections at this facility

  • 1273626 (VAI Tue Aug 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196871 (OAI Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029761 (VAI Wed Oct 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969790 (VAI Tue Apr 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823447 (NAI Fri Mar 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
138821 CFR 211.101(d)Component addition checked by 2nd person
150521 CFR 211.122(d)Label storage access limited to authorized personnel
154021 CFR 211.125(a)Strict control not exercised over labeling issued
197521 CFR 211.182Written records kept in individual logs
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation