FDA 483 - rms Company - May 18, 2022

An FDA inspection of rms Company in Minneapolis, MN, revealed inadequate procedures for controlling non-conforming products. The firm's non-conformance and containment procedures were not adequately defined or followed, leading to instances where product disposition occurred prior to recorded meetings and required containment forms were not used. These findings indicate deficiencies in the firm's quality system regarding the management of non-conforming materials.