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657372

ULTRAtab Laboratories, Inc. — FEI 3003068822

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 5, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Highland, NY (United States)

Facility

Other inspections at this facility

  • 1219486 (OAI Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151570 (OAI Tue Sep 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116566 (OAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078170 (VAI Fri Feb 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065575 (VAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
435521 CFR 211.165(c)Sampling and testing plans not followed
438921 CFR 211.198(a)Procedures to be written and followed