We have previously written that one of the new trends in enforcement in the life sciences industry is the focus the federal government is having on compliance with current good manufacturing practices (cGMP).
For instance, we noted back in February of this year that the U.S. Department of Justice announced that compliance with current good manufacturing practices (cGMPs) will be one of the agency's "top areas of focus" in the coming year." Additionally, we recently noted that DOJ has been probing international pharmaceutical manufacturing, investigating several companies and their manufacturing practices over the last several months.
Most recently, DOJ filed a lawsuit on behalf of the FDA against Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger, as reported by FiercePharmaManufacturing. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops, including a lacking of procedures to protect against microbiological contamination. Among other issues, a 2011 FDA warning letter said the company had released several batches of sterile ophthalmic eye drops without adequately validating aseptic processes, and wasn't testing the water used to make the drops.
- See more at: http://www.policymed.com/2013/12/trends-in-fda-cgmp-violations.html#sthash.denFL6W0.dpuf
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