FDA Inspection 1319030 — West Medical Supplies
The FDA completed an inspection of West Medical Supplies on May 26, 2026 in Hallandale Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hallandale Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23032 | ISO 13485:2016 Clause 4.2.1 | Quality management system documentation not adequate |
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |