FDA 483 - Chromo Laboratories India Private Limited - August 10, 2024

Chromo Laboratories India PVT. LTD. in Patancheru Mandel, India, was inspected and received a Form 483 with 9 observations. The inspection revealed significant deficiencies across quality control, quality unit oversight, equipment maintenance, record management, environmental controls, and employee training. These issues indicate a systemic failure to adhere to GMP requirements for the manufacture and storage of intermediates and APIs.