FDA 483 - Sun Pharmaceutical Industries Ltd. - June 13, 2025

Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, was cited for significant deficiencies in its sterile drug manufacturing and quality control processes. The inspection revealed repeat observations related to poor aseptic technique, inadequate environmental monitoring, and insufficient media fill validation, alongside failures in equipment design, investigation procedures, and stability testing, resulting in multiple batch rejections and the distribution of potentially compromised products to the US market.