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1240761

Dental Technologies, Inc. — FEI 1413475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 14, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lincolnwood, IL (United States)

Facility

Other inspections at this facility

  • 1177938 (OAI Tue Jul 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1135854 (OAI Wed Jan 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082266 (VAI Tue Mar 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054744 (NAI Tue Apr 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023790 (NAI Thu Jun 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
313021 CFR 820.100(a)Lack of or inadequate procedures
344521 CFR 211.65(a)Equipment construction - reactive surfaces
430321 CFR 211.67(b)Written procedures fail to include
54621 CFR 820.75(a)Lack of or inadequate process validation