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1270809

K.W. Griffen Company — FEI 1211177

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 16, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Norwalk, CT (United States)

Facility

Other inspections at this facility

  • 1232979 (VAI Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062093 (VAI Tue Aug 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 771859 (VAI Tue Feb 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698666 (VAI Thu Nov 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 630664 (NAI Mon Nov 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
150521 CFR 211.122(d)Label storage access limited to authorized personnel
363221 CFR 211.170(b)Annual visual exams of drug products