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1065575

ULTRAtab Laboratories, Inc. — FEI 3003068822

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2018
Fiscal Year
2018
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))
  • 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
109821 CFR 211.22(c)Approve or reject procedures or specs
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
189021 CFR 211.165(e)Test methods