FDA 483 - Arch Pharmalabs Ltd. - September 12, 2025

An FDA inspection of Arch Pharmalabs Ltd. in Dombivli, Maharashtra, an API manufacturer, revealed significant deficiencies across multiple areas. Issues included inadequate environmental monitoring and alarm systems, poor facility design leading to potential contamination, incomplete batch production records, and a lack of quality unit approval for critical changes. Additionally, the suitability of testing methods was not properly verified, and raw material weighing devices lacked suitable accuracy, indicating systemic quality control and documentation failures.