FDA 483 - Bhargava Phytolab Private Limited - July 26, 2024

The FDA inspected Bhargava Phytolab Private Limited in Bhiwadi, India, a drug manufacturer, revealing significant deficiencies across multiple systems. The inspection cited inadequate component testing, poor facility maintenance, unvalidated cleaning processes, and failures in quality control, record-keeping, and deviation investigations. These issues indicate a lack of robust controls to ensure drug product quality, purity, and identity.