FDA Slams Boehringer-Ingelheim With New Warning Letter
May 27th, 2013 // 1:50 pm @ jmpickett
Latest FDA and cGMP Compliance News
Boehringer-Ingelheim was hit with a warning letter for two API and two cGMP observations this month. Also, the API and drug facility in Germany was hit for its failure to respond with appropriate corrective actions after the first 483 it received in 2012.
In the API area, FDA hit Boehringer’s quality division for not investigating deviations in its manufactured APIs in 2008 and 2009. This observation was based upon an inspection done in November 2012. The firm also did not determine where foreign particles were coming from and continued to use lots of API that were contaminated with such particles.
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This German site is one of the nine facilities the company uses to manufacture drugs around the world.
FDA stated in the warning letter that it was very concerned about eh inability of the company to prevent foreign particles from showing up in APIs and the lack of proper action to address this situation. Anyone who is familiar with warning letters knows that when FDA uses language such as this, it can mean big trouble for pharmaceutical companies. As one of our upcoming webinars points out, warning letters and 483s with this sort of language often end up resulting in recalls and consent decrees down the road.
In the area of finished products, FDA also criticized Boehringer because it released capsules where there were very large foreign particles. Some of these were 5 mm in size and weight up to 9 mg. The agency noted that it did not agree with the decision of the company to use these drugs even though the batches that were contaminated met final specs.
FDA warned that quality can’t be added into the product after it has been made.
The firm also did not determine what caused an OOS lot for Spiriva HandiHaler, which failed a uniformity of delivered dose test specification test.
Right before the inspection by FDA of the plant in Ingelheim, Boehringer announced that it planned to invest about $100 million in a manufacturing plant in Dortmund. That was part of a plan to make more Respimat inhalers, which is what the delivers the Spiriva medicine.
