FDA WARNING_LETTER - United Exchange Corporation - April 06, 2018

The FDA inspected United Exchange Corporation's drug manufacturing facilities in Cypress and Rialto, CA, from April 2-6, 2018, identifying significant CGMP violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to establish an adequate quality control unit (QCU)** with proper authority and written procedures (21 CFR 211.22(a) and (d)). * **Inadequate QCU oversight of contract manufacturers (CMOs):** The firm used multiple sub-standard CMOs, leading to FDA actions against six of them since 2016. The company's response regarding discontinuing relationships and acknowledging audit deficiencies was deemed inadequate, lacking details on requalification, risk assessment for current products, and scientific justification. * **Inadequate batch review/release:** The firm failed to perform final batch reviews for disposition. Their response was insufficient, lacking details on new procedures, drug product specifications, risk assessments for previously released products, and test results. * **Inadequate QCU procedures:** Procedures for handling investigations, deviations, specification failures from contractors, and the receipt, examination, and storage of incoming drug products were deficient. Quarantined and released products were stored together. The company's response lacked details on new procedures and facility improvements.