FDA 483 - Primrose Medical Inc. - October 26, 2022

Primrose Medical Inc., a manufacturer of Class II medical devices in East Walpole, MA, received 11 observations during an FDA inspection. The observations primarily highlight significant deficiencies in the firm's quality system, particularly concerning design controls, risk analysis, CAPA procedures, complaint handling, supplier controls, personnel training, and internal audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.