FDA 483 - Nang Kuang Pharmaceutical Co., Ltd. - April 02, 2024

Nang Kuang Pharmaceutical Co., Ltd. in Tainan City, Taiwan, was inspected by the FDA, revealing significant deficiencies across multiple areas. The inspection found issues with drug product container integrity, inadequate investigations into discrepancies, and compromised laboratory and environmental controls. These observations indicate a lack of robust quality systems, potentially impacting drug product safety, identity, strength, quality, and purity.