FDA 483 - Orca Biotech LLC - August 05, 2021

An FDA inspection of Orca Biotech LLC in Sandy, UT, a biological drug own-label distributor, revealed significant deficiencies. The firm failed to establish complete master production and control records, lacked strict control over drug product labeling operations, and did not adequately handle customer complaints. These issues indicate a lack of robust quality control and regulatory compliance for their distributed biological drug products.