FDA WARNING_LETTER - B.M.P. Pharma Trading AG - November 16, 2011

An FDA inspection of B.M.P. Bulk Medicines & Pharmaceuticals GmbH's API manufacturing facility in Norderstedt, Germany, from November 14-16, 2011, revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The primary violation identified was the firm's failure to use dedicated production areas, including facilities and air handling equipment, for beta-lactam products. This led to cross-contamination risks, as sampling and repackaging of beta-lactam and non-beta-lactam products occurred in shared facilities with shared equipment and dust collection hoods, notably with common ductwork. The firm's existing procedures were deemed insufficient to prevent such contamination. To achieve compliance, B.M.P. Pharma Trading AG must cease all beta-lactam operations until facilities are completely segregated and robust procedures are implemented to prevent cross-contamination. The company is required to submit a comprehensive decontamination plan, including sampling, baseline contamination data, and analytical methodology to demonstrate effective remediation, or remove contaminated surfaces/equipment. Failure to correct these deviations may result in FDA withholding approval of new applications and refusing admission of products into the U.S. A written response detailing corrective actions and timelines is required within fifteen working days.