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1101266

Elevate Oral Care — FEI 3009603151

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Palm Beach, FL (United States)

Facility

Other inspections at this facility

  • 1285290 (NAI Tue Sep 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1271193 (NAI Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218722 (NAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031595 (OAI Fri Nov 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941446 (VAI Fri Aug 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed
440221 CFR 211.192Written record of investigation incomplete