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1062093

K.W. Griffen Company — FEI 1211177

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 14, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Norwalk, CT (United States)

Facility

Other inspections at this facility

  • 1270809 (VAI Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1232979 (VAI Fri Mar 15 2024 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
145021 CFR 211.113(a)Procedures for non-sterile drug products
202621 CFR 211.192Quality control unit review of records
354721 CFR 211.46(b)Equipment for Environmental Control
362321 CFR 211.170(a)Active ingredient retained sample kept
430921 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action