FDA 483 - Makson Health Care Private Ltd. - September 29, 2022

Makson Health Care Private Ltd. in Anharam, Telangana, India, an OTC drug manufacturer, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across quality control, complaint handling, laboratory controls, and facility management, indicating a lack of adherence to established procedures and good documentation practices. Issues included inadequate supplier oversight, destroyed training records, unvalidated test methods, and improper storage conditions, suggesting a systemic breakdown in quality assurance.