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557687

Abbey Color Incorporated — FEI 2518563

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 20, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1116297 (VAI Wed Jan 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910419 (VAI Tue Jan 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773915 (OAI Fri Mar 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 674934 (VAI Thu Aug 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
194321 CFR 211.180(e)(1)Review of representative number of batches
203121 CFR 211.194(a)Complete test data included in records
361321 CFR 211.160(b)(4)Establishment of calibration procedures