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827113

ABBE Laboratories, Inc. — FEI 3004433842

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 12, 2013
Fiscal Year
2013
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))
  • 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
145021 CFR 211.113(a)Procedures for non-sterile drug products
192021 CFR 211.166(a)(3)Valid stability test methods
200321 CFR 211.184(c)Individual inventory record
363221 CFR 211.170(b)Annual visual exams of drug products
430621 CFR 211.80(a)Written Procedures Not Followed
432021 CFR 211.84(d)(6)Microbiological Contamination Exam
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications