Bhargava Phytolab Private Limited – FDA Warning Letter, Jul 26, 2024

The FDA issued a Warning Letter to Bhargava Phytolab Private Limited following an inspection from July 22-26, 2024, at their Bhiwadi, Rajasthan, India facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and deviations for active pharmaceutical ingredients (API), rendering their drugs adulterated.

Key violations include: 1. **API CGMP Deviations:** Failure to adequately test APIs for conformance to specifications (e.g., heavy metal limit testing on certain APIs) and lack of process validation for API production. The firm relied on supplier COAs without sufficient internal testing or validation. 2. **Raw Material Testing:** Failure to ensure scientifically sound test procedures for raw materials, specifically relying on vendor COAs for impurities in a component without adequate testing or contract laboratory qualification. 3. **Finished Drug Product CGMP Violations:** Inadequate written procedures for production and process control, including issues with the water system design (dead leg, no continuous circulation, insufficient monitoring) and lack of validation for the water system. 4. **Sterile Product Contamination Prevention:** Failure to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, specifically lacking media fills for aseptically filled products.

The FDA acknowledged the firm's commitment to cease sterile drug production for the U.S.