Major Shake Up at Boehringer After Warning Letter Disaster

Major Shake Up at Boehringer After Warning Letter Disaster

May 22nd, 2013 // 3:58 pm @

Latest FDA and cGMP Compliance News

Due to a long list of serious cGMP manufacturing problems, Boehringer Ingelheim is doing a major overhaul of its management team.

Last week, the firm quietly put up on its website that a member of its board of managing directors – Wolfram Carius – is leaving the company after 25 years. He is going to be replaced by Wolfgang Baiker, who was the head of worldwide development.

The resignation is happening just after Boehringer got a nasty warning letter from FDA about major cGMP violations at its plant in Rhein, Germany. There FDA inspectors found serious problems with APIs and finished drugs. One of them including the huge-selling Spiriva, and the company also failed to take proper corrective actions.

What is the connection between the FDA warning letter and the departure of Carius? A spokesperson for the company stated that the firm is making major changes to the leadership of operations. The company also is doing a major review of the company’s operations network to make sure that the issue is resolved.

According to the recent warning letter, Boehringer did not conduct complete investigations to find out the sources of foreign particles in their APIs. These were known in 2009, but FDA should have done a complete review in 2008. Some lots that had foreign particles were used in production and there was no effort taken to do anything about their presence until last year.

Also, the company provided inconsistent findings after a complaint about there being foreign particles in a drum of APIs. FDA stated that it was very concerned about the firm’s ability to stop the presence of such foreign particles in the APIs and what they are doing to stop these situations from recurring.

Boehringer also did not reject several batches of a certain capsule that had contamination with various foreign matter. The company also did not figure out why Spiriva lots did not have proper delivered dose specs during a period of nine months.

FDA stated in the warning letter that the same lot also did not have the proper uniformity of delivered dose during a 12 month stability interval. It was only after the OOS result at 12 months that the company decided to do a product recall for this lot of Spiriva. FDA noted that is is concerned that management decided to let adulterated products to stay in the market.

Boehringer has had major cGMP violations in the recent past. In 2010, Ben Venue Labs had major systemic problems that netted a consent decree. There were many product recalls and shortages. Boehringer stated that its problems were more due to problems with capacity and not related to quality problems.

However, FDA found many problems, such as metallic flakes that were in some drugs, and inspectors thought it came from door or window frames. There also was rain water coming through the ceiling, and operators had gloves that were non sterile. These details  were noted in a 483, which included a quite unusual mystery. There was a strange liquid found in large can in a storage area as one of its warehouses. It was found that the liquid was urine, but a risk assessment was not performed at the time. Ben Venue did provide a report to the police but they gave the police an empty can, and the police did not get DNA or any prints from it.

All of these details help to explain the latest management changes at Boehringer. The Ben Venue consent decree was handed out by FDA only in 2012, and FDA is looking into serious cGMP problems with the company’s largest drug. So, there is a chance that these serious cGMP problems could affect other drugs at the firm.


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