# FDA 483 - Welmed Inc. - March 23, 2022

Source: https://www.globalkeysolutions.net/records/483/welmed-inc/f7fed4af-0536-4d7a-a0e3-09c98a3fc5a2

> FDA 483 for Welmed Inc. on March 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Welmed Inc.
- Inspection Date: 2022-03-23
- Product Type: device
- Office Name: Chicago District Office
- Summary: Welmed Inc., a specification developer in Chicago, IL, received a Form 483 with four observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including inadequate procedures for Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and supplier management. Additionally, internal quality audits were found to be conducted by individuals with direct responsibility for the audited matters, compromising auditor independence.

## Related Officers

- [Brittani N. Franklin](https://www.globalkeysolutions.net/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

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

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