FDA 483 - DSAART LLC - May 15, 2019

Aesthetic and Reconstructive Technologies, Inc. in Carson City, NV, was cited with 11 observations during an FDA inspection, primarily concerning significant deficiencies in its quality system for medical device manufacturing. Key issues include unvalidated sterilization and heat sealing processes, inadequate equipment calibration and maintenance, and failures in managing nonconforming products, supplier agreements, CAPA, quality audits, and management reviews. The findings indicate a broad lack of adherence to established procedures and regulatory requirements.