FDA 483 - Sunstar Guangzhou Ltd. - June 28, 2019

Sunstar Guangzhou Ltd., an OTC (b)(4) manufacturer in Guangzhou, China, was cited for multiple significant deficiencies across its quality, laboratory, and production systems. Key issues include inadequate written procedures for quality reviews, GMP training, and quality control unit responsibilities, as well as failures in drug product testing, laboratory controls, and record-keeping. These observations indicate a systemic lack of adherence to current good manufacturing practices.