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1262223

ABBE Laboratories, Inc. — FEI 3004433842

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 27, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Facility

Other inspections at this facility

  • 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))
  • 724721 (VAI Thu May 05 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
439121 CFR 211.180(e)(2)Items to cover on annual reviews