FDA 483 - Polaroisin International Co., Ltd. - September 15, 2017

Polaroisin International Co., Ltd., an OTC drug manufacturer in New Taipei City, Taiwan, was cited for significant deficiencies across its laboratory, production, and quality control systems. The inspection revealed inadequate finished product testing, poor record-keeping practices, lack of supplier qualification, and an absence of critical validation and stability programs. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of drug products shipped to the U.S. market.