FDA 483 - Custom Healthcare Systems of VA, LLC - October 26, 2022

An FDA inspection of Custom Healthcare Systems of VA, LLC in Richmond, VA, a medical device manufacturer, revealed two significant quality system deficiencies. The firm failed to adequately establish and implement sampling procedures, using an outdated sampling standard and not following its own procedures for finished product sampling. Additionally, the company did not perform required internal quality audits at defined intervals during 2020 and 2021.