FDA EIR - Wuxi STA Pharmaceutical Co., Ltd - March 03, 2023

An FDA inspection was conducted at Wuxi STA Pharmaceutical Co., Ltd, a contract drug manufacturer, from February 27 to March 3, 2023. The inspection focused on the finished drug product for specific tablets. At the conclusion, a single FDA Form 483, Inspectional Observation, was issued to Mr. Dirk Tormans, Vice President, Head of STA Quality Assurance. The primary issue identified was that routine calibrations of mechanical measuring instruments were not performed according to the company's established written procedures. This observation falls under the regulatory framework of Current Good Manufacturing Practices (cGMP), which governs the quality control and manufacturing processes for pharmaceutical products. In response, Wuxi STA Pharmaceutical's management committed to correcting the deficiency and providing a written response to the FDA within 15 business days. The FDA classified this inspection as "Voluntary Action Indicated (VAI)," signifying that while an objectionable condition was noted, it does not currently warrant direct regulatory enforcement action, expecting the firm to voluntarily rectify the issue. The company's drug registration remains current.