Boehringer-Ingelheim has responded to a warning letter issued by the US Food and Drug Administration that faults the company for not correcting "significant violations" of good manufacturing practice at its facility in Rhein, Germany.
During an inspection in November, the FDA found foreign particles in batches of active pharmaceutical ingredients produced at the facility in 2008 and 2009.
The FDA has criticised the company in a warning letter issued on May 6 for not carrying out investigations to determine the source of these particles, and not implementing "timely and appropriate" corrective and preventive actions.
In a statement published today, Boehringer said it was taking the issue "very seriously" and is committed to address the FDA’s concerns.
Boehringer head of Corporate Division Quality Dr Gerhard Koeller said: "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."
The firm was also faulted for failing to reject multiple batches of capsules contaminated with foreign particles in 2010 and 2012.
The FDA pointed out that a batch of Spiriva HandiHaler, a drug approved for the treatment of chronic obstructive pulmonary disease, had failed to give a uniform dose when tested at nine months but that the company did not recall the lot until it again fell out of specification after 12 months.