Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has issued a warning letter concerning its manufacturing practices following an agency inspection in Ingelheim, Germany in November 2012. The matter also concerned foreign particles detected in batches of active pharmaceutical ingredients.
“Boehringer Ingelheim is taking this issue very seriously and is fully committed to working with the FDA on a comprehensive action plan that addresses the FDA’s concerns, ensuring that it implements corrective and preventive actions to optimise its quality systems. We are committed to compliance with current Good Manufacturing Practices requirements. We will invest all our energy to remedy the situation in order to meet all FDA requests, building on the experience gained from all 22 inspections successfully passed at the Ingelheim site in the last five years by different authorities around the world, other than the latest FDA inspection in November” said Dr Gerhard Koeller, Head of Corporate Division Quality at Boehringer Ingelheim.