Is it ever legitimate for FDA to add companies to an FDA import alert without notice? No. Does FDA do this anyway? Yes, and frequently. In April 2013, many Chinese OTC drug manufacturers fell victim to FDA’s caprice.
In 2012, FDA conducted a series of surprise inspections of Chinese OTC drug manufacturers. The FDA inspectors found a host of current Good Manufacturing Practices (cGMPs) violations. However, after a series of letters between the companies and the FDA, the agency delayed its actions for over 12 months and then suddenly placed the companies onto FDA Import Alert.
Between February and March 2013, without any formal notice, FDA started adding companies to Import Alert 66-40 (“Detention without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs.”). This happens when an FDA inspection reveals that a firm is not operating in conformity with cGMPs. However, when following its own procedures, FDA promptly issues notification of noncompliance via an FDA warning letter or untitled letter. FDA then gives the firm an opportunity to make corrections before adding them to an FDA Import Alert.
In this case FDA issued the Import Alert before issuing any notification to the firms. By February and March 2013, the companies had already shipped hundreds of containers to the USA. No known adverse events occurred as a result of use of the manufacturers’ product. No major recalls have been initiated. Even after firms were added to the Import Alert, FDA did not press for or even suggest a recall was appropriate. Yet, without notice, FDA placed those manufacturers on the Import Alert. US importers were stuck with shipments under an FDA automatic detention that may never be released, resulting in significant losses.
Lack of Notice
Federal law, the FDA regulations and, of course, the U.S. Constitution, require FDA to give adequate notice to importers prior to detaining or refusing imported shipments. In this case, the very first time anyone became aware of the FDA Import Alert listing was when FDA issued its first automatic detentions to the importers. In our opinion, that is not notice.
The consultants and affiliated attorneys at FDAImports.com use their expertise to troubleshoot all FDA Import Alert and automatic detention issues. We correlate the law, facts and FDA procedures of each case to ensure FDA does what the law allows – and no more. Contact us today if you find yourself unexpectedly on Import Alert – we may be able to resolve your dilemma.
