FDA fails to inspect large percentage of cosmetics, research finds; only an estimated 115 of 5,000 cosmetics firms are inspected annually, according to new data
December 28, 2011
– The U.S. Food and Drug Administration (FDA) failed to inspect a large percentage of drug makers, device makers and cosmetics firms, the Milwaukee, Wisconsin-based Journal Sentinel reported on Dec. 27.
The Journal Sentinel evaluated FDA inspection data since 1999, and discovered that firms across various industries have not received FDA inspection. Although the FDA is obligated to inspect drug makers every two years, data revealed that 1,400 drug firms have not been inspected for five years or longer.
The Journal Sentinel found that approximately 25% of 7,000 U.S. drug firms were inspected last year, while approximately 11% of device makers received inspections.
A cosmetics company is not required to notify the FDA if its products cause serious illness or injury. Industry analysts estimate there are 5,000 cosmetics firms in the U.S. and an undetermined number overseas. The FDA only inspects around 115 cosmetics firms annually.
The director of the FDA’s Office of Regional Operations, David Elder, said the FDA does its best to conduct inspections with the resources it has. The FDA has expanded the number of inspectors to 1,800, but still does not have adequate resources to inspect all facilities. As a result, it uses a risk-based approach to determine which organizations it inspects.
The primary source of this article is the Journal Sentinel, Milwaukee, Wisconsin, on Dec. 27, 2011.