Abbott Labs Leads in FDA Pharmaceutical Safety Inspection Failures
According to data from the Food and Drug Administration, safety violations at pharmaceutical plants increased in 2010. The administration found safety violations at 54% of the plants that were inspected last year, which was a spike of 20% from 2007. Leading the pack in failure to clear safety inspections was Abbott Labs.
Abbott Labs failed about 59% of its 111 inspections. It was followed by Pfizer, which failed 57% of 202 inspections. Merck failed 15% of 134 inspections by the FDA and last year’s recall czar Johnson & Johnson failed 40% out of 161 inspections. Some of the best results were achieved by Mylan, which passed 79% of 56 inspections last year. Overall, 80 drug makers failed more than 50% of their FDA inspections.
The analysis was conducted by Bloomberg, and included data from 10,000 inspections at American pharmaceutical plants between 2000 and September 30, 2010. The analysis initially placed Pacira Pharmaceuticals at first place in the number of flunked safety violations, stating that the company had an 82% rate of failing inspections. However, the analysis is from 2010, and since then the company has changed hands to new management.
Inspections by the FDA are a vital component of our pharmaceutical safety mechanism. Experience and past studies have shown that when the number of FDA inspections drops, consumers and patients may be at a higher risk from defective and dangerous pharmaceutical products and drugs. On an average, the Food and Drug Administration makes up to 0.9 visits to each drug manufacturing facility in the United States. That may seem like a low number, but it means that the Food and Drug Administration pays a visit to each of the 2,567 pharmaceutical plants within the United States, at least once every year. That is also an increase from the 0.6 visits that the agency used to make while the George Bush administration was in power.
While the Food and Drug Administration has been able to increase the number of visits that it makes to domestic pharmaceutical production facilities, pharmaceutical liability lawyers would like the agency to step up its efforts to inspect foreign pharmaceutical plants. Many ingredients that are used in vital pharmaceutical products inside the US are now manufactured overseas, in countries like China. However, strained resources have meant that the Food and Drug Administration is not able to send as many inspectors to these facilities as it needs to. Some facilities in China, for instance, have not been inspected for years. The lack of inspections of foreign pharmaceutical facilities that manufacture drugs consumed by Americans, was seen in the heparin scandal a couple of years ago. That scandal led to several deaths, and was ultimately traced to contaminated heparin from China. That facility had not been inspected for years.
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