FDA EIR - Emcure Pharmaceuticals Limited - December 28, 2018

An FDA pre-approval inspection was conducted at Emcure Pharmaceuticals Limited in Pune, Maharashtra, India, from December 27-28, 2018. The inspection, guided by Current Good Manufacturing Practices (21 CFR 210/211) and ICH Q7 guidelines, focused on the facility's readiness for commercial manufacturing of an Active Pharmaceutical Ingredient (API) for the U.S. market. At the conclusion, a 3-item FDA Form 483 was issued, highlighting significant observations. Main issues included the lack of established and documented accuracy for analytical methods, inadequate adherence to Quality Control and Quality Assurance responsibilities, and insufficient cleaning and maintenance of equipment and utensils to prevent contamination or malfunction. Specific concerns involved a raw material supplier that had not been re-qualified after a status change and the presence of dried paint on manufacturing equipment without a risk assessment. Emcure Pharmaceuticals Limited management acknowledged the findings, committed to addressing all observations through corrective actions, and promised to provide a written response within 15 business days. No samples were collected, and no inspectional refusals occurred.