In its inspection, the federal agency found that the company violated current Good Manufacturing Practice (cGMP) for the manufacture of APIs and the cGMP regulations for finished pharmaceuticals, which is Title 21 Code of Federal Regulations, Parts 210 and 211.
The company, however, said it is fully committed to working with the FDA on a comprehensive action plan that addresses the agency’s concerns, ensuring the implementation of corrective and preventive actions to optimise its quality systems.
Boehringer Ingelheim head of corporate division quality Gerhard Koeller said, "We are committed to compliance with current Good Manufacturing Practices (GMP) 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 5 years by different authorities around the world, other than the latest FDA inspection in November," Koeller added.