FDA 483 - Madhu Instruments Private Limited - October 21, 2022

An FDA inspection of Madhu Instruments Private. Limited. in New Delhi, India, a finished sterile drug product manufacturer, revealed significant deficiencies across its quality system. The firm exhibited widespread data integrity issues, inadequate investigations into discrepancies and complaints, and a lack of proper employee training. Additionally, the facility suffered from poor maintenance, insufficient environmental controls, and a failure to validate equipment and processes, all of which compromise the quality and safety of their drug products, particularly (b)(4) mg USP.