FDA 483 - CTX Lifesciences Private Ltd. - February 16, 2019

CTX Lifesciences Private Ltd. in Surat, India, an API manufacturer, received a Form 483 for significant deficiencies in its quality unit's oversight of CGMP compliance. The inspection revealed failures in managing out-of-specification results, inadequate employee training, and a lack of control over transportation conditions for Active Pharmaceutical Ingredients. These issues indicate a systemic breakdown in quality assurance and control.