FDA Inspection 1327390 — Hart Enterprises Of The U.S.A., Inc.
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
| ID | CFR | Description |
|---|---|---|
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |