Regulatory Focus™ > News Articles > New FDA Standard on Cargo Theft Released

New FDA Standard on Cargo Theft Released

Posted 03 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released a new standard operating procedure (SOP) for staff outlining how FDA responds to cargo thefts.

The 23 March SOP, FDA'S Response to Cargo Thefts, intends to "provide a general procedure for determining FDA's regulatory response when a cargo theft involving an FDA-regulated product has occurred," writes FDA.

"FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including prescription and over-the-counter medicines, vaccines, medical devices and infant formula," explains FDA in the SOP. "These crimes threaten the public health because product that has left the legitimate supply chain poses potential safety risks to consumers."

The SOP notes FDA plans to disseminate cargo theft information to the public on an as-needed basis. FDA reserves the right to do this without a firm's cooperation, particularly if the firm is "nonresponsive to FDA's request for information" or if the firm's plan of action is "inadequate."


Read more:

FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVES: GENERAL OR ULTIDISCIPLINE - FDA'S RESPONSE TO CARGO THEFTS


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