FDA EIR - Yung Shin Pharmaceutical Industry Co., Ltd. - September 12, 2019

An FDA pre-approval inspection of Yung Shin Pharmaceutical Co., Ltd. in Tachia, Taiwan, was conducted from September 9-12, 2019. This inspection, carried out under the regulatory framework of CP 7346.832 for Pre-Approval Inspections, evaluated the manufacturing facility for specific tablet products. The inspection was classified as "Voluntary Action Indicated" (VAI). Main issues observed included deficiencies in laboratory controls, specifically the lack of scientifically sound specifications to ensure drug product identity, strength, quality, and purity. Furthermore, drug products were not stored under conditions appropriate to maintain their identity, strength, quality, and purity. Following the inspection, an FDA-483 form detailing these observations was issued to company management. Yung Shin Pharmaceutical committed to providing a formal written response within 15 business days. Although the inspector recommended an "acceptable" status for the firm's manufacturing role, the final decision regarding the acceptability of the inspected tablets will be made by the FDA's Center for Drug Evaluation and Research (CDER).