FDA 483 - Ramdev Chemical Private Limited - December 05, 2025

An FDA inspection of Ipca Laboratories Limited in Palghar, Maharashtra, India, an API manufacturer, revealed significant deficiencies across three observations. These included inadequate facility maintenance leading to potential contamination, deficient analytical method verification studies for API testing, and a lack of controls to prevent carryover of residual materials between manufacturing batches. The findings indicate a need for improved quality systems and manufacturing controls to ensure product quality for the US market.