FDA Inspection 1328452 — Sure-Tech Diagnostic Associates, Inc
The FDA completed an inspection of Sure-Tech Diagnostic Associates, Inc on Jul 29, 2026 in Saint Louis, MO. 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 29, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23033 | ISO 13485:2016 Clause 4.2.1 | QMS documentation does not include required documents |