FDA 483 - Yino, Inc. (Trading Company) - March 22, 2019

Yino Inc., an API trader in Yubei District, Chongqing, China, was cited for significant deficiencies related to its Certificates of Analysis. The firm issued COAs that lacked essential information for traceability to the original API manufacturer, including missing names and addresses, unauthorized signatures, incorrect test results, and inconsistent batch numbers. These issues indicate a severe lack of control over critical documentation for active pharmaceutical ingredients.