FDA 483 - Cdymax (India) Pharma Private Limited - May 17, 2019

An FDA inspection of Acebright (India) Pharma Private Limited, an API drug manufacturer in Jigani, India, revealed a significant deficiency in laboratory controls. The firm failed to establish scientifically sound test procedures, specifically by not using a second working standard solution during chromatographic analysis to confirm the potency, accuracy, and purity of active pharmaceutical ingredients. This indicates a serious lapse in quality control for their drug products.