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

The FDA issued a Form 483 to Bhargava Phytolab Private Limited following an inspection of their drug manufacturing facility in Bhiwadi, Rajasthan, India, from July 22-26, 2024. The inspection revealed significant deficiencies across several critical systems, indicating a failure to adhere to Current Good Manufacturing Practices.

Key issues included a deficient **Materials System**, where the company failed to perform necessary testing for active pharmaceutical ingredients and excipients, relying instead on supplier certificates without proper identity or quality verification. Furthermore, there was no supplier qualification for a critical excipient vendor.

The **Facilities and Equipment System** exhibited poor maintenance, with observations of animal excrement, open exterior building access, pervasive mold and discoloration, and general unsanitary conditions in production areas. Manufacturing equipment was found to be unclean, with rust and discoloration, and lacked cleaning validation.

Deficiencies in the **Quality System** included a failure to thoroughly investigate manufacturing deviations, out-of-range critical process parameters, and environmental excursions in storage. Notably, the Quality Control Unit released drug product batches for distribution before all required testing was completed.

Finally, the **Production System** showed a lack of established written procedures for process controls, deviations from validated processes, unqualified water systems, and incomplete batch records, particularly regarding the traceability of raw material lot numbers.

Bhargava Phytolab is expected to implement prompt and comprehensive corrective actions to address these serious observations and ensure compliance with regulatory standards for drug product quality.