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1116566

ULTRAtab Laboratories, Inc. — FEI 3003068822

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 31, 2020
Fiscal Year
2020
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))
  • 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))
  • 954453 (VAI Mon Dec 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
127021 CFR 211.68(b)input/output verification
189021 CFR 211.165(e)Test methods
363221 CFR 211.170(b)Annual visual exams of drug products