FDA EIR - Virchow Biotech Private Limited - November 07, 2014

An FDA Pre-Approval Inspection of VIRCHOW BIOTECH PVT LTD in Hyderabad, India, took place from November 3 to November 7, 2014. This inspection evaluated the facility's compliance with Current Good Manufacturing Practices (21 CFR 210/211) for drug manufacturing, particularly focusing on a drug product transfer. The inspection identified five significant issues, documented on an FDA-483 form. Main violations included the lack of a formal assessment for variable or nonlinear stability test results and insufficient system suitability requirements in HPLC assay methods, which did not mandate %RSD determination throughout chromatographic runs. A critical deviation concerning incomplete peak elution due to mobile phase evaporation was not followed by a Corrective Action Preventative Action (CAPA). Additionally, the firm lacked a written procedure for transferring analytical test methods from a collaborating site, and a specific stability testing method (QC-STP-190) failed to assess interference from other components. Management committed to immediate corrections, including revising stability protocols, updating HPLC procedures, implementing CAPA investigations, revalidating analytical methods, and performing additional method specificity assessments. A written response was promised within 15 days.