FDA Inspection 1320072 — Guardian Medical USA Inc.
The FDA completed an inspection of Guardian Medical USA Inc. on Jun 2, 2026 in Swanton, OH. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Swanton, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23127 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures not documented |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23168 | ISO 13485:2016 Clause 7.5.6 | Planned results not consistently met during validation of processes |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |