FDA 483 - SALUS MEDICAL LLC - May 16, 2019

SAIUS MEDICAL LLC, a packer/repacker in Phoenix, AZ, was inspected by the FDA from May 13-16, 2019. The inspection revealed significant deficiencies in written procedures for labeling, quality control, complaint handling, training, and product storage conditions. These issues indicate a lack of adequate controls to ensure the identity, strength, quality, and purity of drug products.