FDA 483 - Chromo Laboratories India Private Limited - January 24, 2020

Chromo Laboratories India PVT. LTD. in Patancheru Mandel, India, an intermediate and API manufacturer, received a Form FDA 483 with nine observations following an inspection from January 20-24, 2020. The observations highlight significant deficiencies across quality control, data integrity, analytical method transfer, stability studies, cleaning validation, equipment maintenance, environmental controls, and employee training. These issues indicate a broad lack of adherence to cGMP requirements, posing potential risks to product quality and patient safety.