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1150962

Hello Life, Inc — FEI 3009727070

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 2, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grand Rapids, MI (United States)

Facility

Other inspections at this facility

  • 1081816 (OAI Thu Mar 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006524 (OAI Fri Mar 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882934 (VAI Wed Jun 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882929 (VAI Wed Jun 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753362 (VAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
1579921 CFR 111.560(a)(1)Product complaint - quality control review
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls