FDA 483 - Nang Kuang Pharmaceutical Co., Ltd. - June 16, 2022

Nang Kuang Pharmaceutical Co., Ltd in Tainan City, Taiwan (ROC), a sterile drug product manufacturer, was cited for numerous deficiencies during an FDA inspection. The observations highlight significant issues with aseptic processing, including poor operator practices, inadequate environmental controls, and insufficient responses to contamination excursions. Additionally, the firm's quality unit oversight, deviation investigations, visual inspection program, media fills, and equipment qualification studies were found to be inadequate, indicating a broad lack of control over critical manufacturing processes.