FDA 483 - WEG Surgical Solutions - March 08, 2023

WEG Surgical Solutions, a specification developer in Greensboro, NC, received a Form FDA-483 with seven observations during an inspection from March 6-8, 2023. The firm demonstrated significant deficiencies across its quality system, including a complete lack of established procedures for design control, corrective and preventive actions, training, and internal quality audits. Additionally, the company failed to adequately maintain complaint files, control documents, and conduct proper management reviews.