# Welmed Inc. – FDA 483, Feb 19, 2026

Source: https://www.keypedia.com/records/483/welmed-inc/4c8ed25a-247b-45d4-986d-35c848f0387d

> FDA 483 for Welmed Inc. on February 19, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welmed Inc.
- Inspection Date: 2026-02-19
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Welmed Inc., a manufacturer and specifications developer of Class II syringes in Chicago, revealed two significant observations. The firm failed to adequately document justifications for not investigating complaints of foreign material in its Class II syringes. Additionally, Welmed Inc. did not maintain proper records of risk management activities related to product realization, including design risk assessments and new risk analyses for supplier changes.

## Related Documents

- [483 - 2022-03-23](https://www.keypedia.com/records/483/welmed-inc/f7fed4af-0536-4d7a-a0e3-09c98a3fc5a2) — date: March 23, 2022

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/welmed-inc/778f4417-f6f6-466b-97e7-3cde8e60ac5b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669