FDA Inspection 1150962 — Hello Life, Inc

Hello Life, Inc — FEI 3009727070

The FDA completed an inspection of Hello Life, Inc on Sep 2, 2021 in Grand Rapids, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

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

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

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.