FDA 483 - Unetixs Vascular, Inc. - July 30, 2021

Unetixs Vascular, Inc. in Warwick, RI, received a Form FDA-483 with six observations, including two repeat observations, following an inspection from July 7-30, 2021. The inspection revealed significant deficiencies across multiple quality system areas, indicating a failure to adequately establish and follow procedures. Key issues include inadequate corrective and preventive actions, design change control, complaint handling, nonconforming product control, supplier management, and medical device reporting.