FDA 483 - Ashlar Medical LLC - May 09, 2019

Ashlar Medical LLC, a manufacturer of Class II medical devices in Natchitoches, LA, received seven observations during an FDA inspection. The firm was cited for significant deficiencies across its quality system, including failures in design validation, risk analysis, CAPA procedures, supplier controls, medical device reporting, complaint handling, and quality audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.