FDA Inspection 1327390 — Hart Enterprises Of The U.S.A., Inc.

Hart Enterprises Of The U.S.A., Inc. — FEI 1828424

The FDA completed an inspection of Hart Enterprises Of The U.S.A., Inc. on Jul 22, 2026 in Sparta, 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). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 22, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Sparta, MI (United States)

Citations

IDCFRDescription
23155ISO 13485:2016 Clause 7.5.1Production and service provision not adequate

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