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614146

ABBE Laboratories, Inc. — FEI 3004433842

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 25, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Facility

Other inspections at this facility

  • 1262223 (OAI Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063137 (VAI Thu Aug 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892592 (VAI Thu Jul 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827113 (VAI Fri Apr 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783112 (NAI Wed May 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
162621 CFR 211.130Procedures are written, and followed
191421 CFR 211.166(a)Lack of written stability program
356921 CFR 211.89Quarantine of Rejected Components et. al.
439121 CFR 211.180(e)(2)Items to cover on annual reviews