FDA 483 - Roechling Medical Rochester, L.P. - August 02, 2021

An FDA inspection of Roechling Medical Rochester, L.P. in Rochester, NY, a medical device contract manufacturer, identified five observations related to deficiencies in their quality system. The issues included inadequate process validation, lack of statistical rationale for sampling plans, and failures in establishing proper procedures for corrective and preventive actions, rework of nonconforming product, and equipment maintenance. These findings highlight a need for the firm to strengthen its documented procedures and their execution to ensure product quality and compliance.