483
SALUS MEDICAL LLCSALUS MEDICAL LLC – FDA 483, May 16, 2019
Record Details
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.
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ID · c7967cc2-f807-4704-98be-9ba03a39df50
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