# West Medical Supplies – FDA 483, May 26, 2026

Source: https://www.keypedia.com/records/483/west-medical-supplies/cfec867e-aeff-43f5-bef1-83beaebeed9a

> FDA 483 for West Medical Supplies on May 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: West Medical Supplies
- Inspection Date: 2026-05-26
- Product Type: device
- Office Name: Florida District Office
- Summary: West Medical Supplies, an importer and distributor of high-risk Class II and III medical devices in Hallandale Beach, FL, was cited for significant quality management system deficiencies. The inspection revealed a systemic failure to control nonconforming products, evaluate suppliers, establish foundational QMS documentation, and adequately control QMS documents, posing a direct and serious risk to patient safety. The firm distributed nonconforming devices, including those with foreign language labeling, without proper detection or control.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/west-medical-supplies/b09eb42a-f35f-4caa-bd38-620d2b27b61b

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9