FDA 483 - Welmed Inc. - March 23, 2022

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.