Boehringer Ingelheim gets FDA warning letter on cGMP failures

German family-owned drug major Boehringer Ingelheim today (May 22) revealed that the US Food and Drug Administration 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.

In its letter to the company, the FDA said it had identified significant violations of current Good Manufacturing Practice (cGMP) for the manufacture of APIs and the cGMP regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause Boehringer Ingelheim’s APIs and drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

"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 optimize 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 Gerhard Koeller, head of corporate division quality at Boehringer Ingelheim.