FDA 483 - United Exchange Corporation - December 04, 2019
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An FDA inspection of United Exchange Corporation, a distributor in Cypress, CA, revealed significant deficiencies across its operations. The firm lacks adequate written procedures for its quality control unit, fails to properly investigate product complaints, and has not established reliable supplier qualifications or sufficient finished product specifications and sampling plans. These issues indicate a systemic failure in ensuring the quality and purity of drug products.
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