FDA 483 - United Exchange Corporation - December 19, 2019

United Exchange Corporation, a distributor/corporate office in Cypress, CA, was cited for significant deficiencies in its quality control processes for drug products. The firm released eye drops that did not conform to final specifications for active ingredient strength and preservative levels, and failed to ensure appropriate laboratory testing prior to distribution. Additionally, laboratory controls were found inadequate, lacking validated testing methods and proper procedures for contract lab operations.