FDA WARNING_LETTER - Yino, Inc. (Trading Company) - March 22, 2019

The FDA inspected Yino Inc. in Chongqing, China, from March 18-22, 2019, and found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). This renders the firm's API adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to transfer all quality or regulatory information from the API manufacturer to customers, specifically by omitting the original manufacturer's name and address on Certificates of Analysis (COA) for re-labeled API distributed to the U.S. market. This practice compromises supply chain accountability and traceability. Furthermore, the firm failed to establish, document, and implement an effective quality management system, evidenced by COAs lacking signatures and dates from the Quality Unit, inclusion of unperformed test parameters, and a lack of written procedures for re-labeling, drug release, and document control. The FDA strongly recommended engaging a qualified consultant. Yino Inc. was placed on Import Alert 66-40 on August 1, 2019. The firm must conduct a retrospective review of distributed API, notify customers, and provide a plan to establish a robust quality system. Failure to correct these deviations may lead to continued import refusal and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.