Boehringer Ingelheim GmbH'sBen Venue Laboratories unit has resumed limited drug manufacturing at its troubled Ohio plant, as it continues to fix the facility. Ben Venue's troubles caused a shortage of Johnson & Johnson's cancer drug Doxil, as well as supply disruptions and recalls for other products it made on behalf of other drug companies.
Ben Venue said it continues to work with the U.S. Food and Drug Administration and other global regulatory agencies to bring back medicines to market as quickly as possible, "with the highest attention to quality and product safety."
It has invested more than $300 million to upgrade its facilities, making improvements and changes to processes to resolve the manufacturing-related issues that resulted in the voluntary shutdown last year. FDA inspectors last year cited lapses including the presence of metal particles in medicines, bacterial contamination in certain batches of medicine and the discovery of a container in the plant suspected to hold urine. Wonder if they installed more toilets? See Nasdaq.
Posted by Bruce Lehr Oct 25th 2012