FDA 483 - Wello, Inc. - October 10, 2019

Wello, Inc., a medical device manufacturer in Addison, TX, was cited with seven observations during an FDA inspection from October 7-10, 2019. The firm demonstrated significant deficiencies across its quality system, including failures in establishing and implementing procedures for Medical Device Reporting, design verification, supplier evaluation, and complaint handling. Additionally, issues were noted with personnel training documentation, internal quality audits, and management review processes, indicating a broad lack of adherence to regulatory requirements.