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FDA Using Data Base to Check for Shipments Scored as “High Risk” – Devices, Food, Medical Products

Posted Feb 06 2010 2:01pm

This is definitely a step in the “right” direction.  Ultimately the high risk area are going to need the availability to work with carriers as well to fully incorporate a useful system that stands to catch more of these types of shipments.  I spent many years in logistics and had this to say back in October of 2008. Blind shipments should really not be allowed but it goes on in the transportation business all the time.

Blind shipments are what causes confusion and additional time and red tap when it’s time to locate recalled products for an example.  Once again too I have a suggestion in that area that has been totally ignored by the FDAtech denial and time at work here I guess. 

Companies may not lie about the product on a certificate of originbut individuals packages may not show the countrycity etc. on where the product comes from and in the age of transparency we need to know this as the global economy continues to grow.  I hope the data base does contain a full listing of those certificates for the research to be successful and help promote better safetya againa local bill of lading could very well be “blind” to all the data contained.

Actually carriers would be very happy not to have to deal with blind bills of ladingbut with contract negotiations to handle a huge accountcompanies wheel this into the contractthen the carrier has to determine how to connect data and maintain records.  Did you know that when product recalls occurbe thankful to the carriers as sometimes companies who negotiate these contracts rely on their IT system to help locate products!  Who would ever thought a little logistics information way down the road here would have some useful information to add (grin).  US Customs data bases here are also part of this puzzle for focus as they carry on normal inspections in just the nature of their business with imported product that is coded with the harmonizing data base to identify product.  image

Just like healthcareeverything is coded and there are people who work for compliance in this area called “customs house brokers” that do just like billing and research companies do with healthcare.  Who knows one day the food you consume could even be linked back to a diagnosis based on the document number referenced upon import (grin) and you will know that it has been certified scanned by the FDA at the port origin.  Whoa….a few too many algorithms for me on a Saturday!  BD 

Carriers also have pallet exchange agreements with companies too and perhaps some of these may have been helpful in the recent Johnson and Johnson recall of to help locate where some of the affected treated pallets were throughout their system.

From October 2008:

“The reason for mentioning this is that a vendor of a food product could have a shipping document that shows a US point of shippingin other wordsthe delivery document that is signed at the time of delivery on “blind” shipments would not indicate to the vendor where the product originatedas well as a purchase orderthus the tracking and delay time in getting this information to the end consumers.  

A “blind” shipment is when you have ABC Company in let’s say ChicagoIL that has product made overseas and distributes all over the world. The product may only show Chicago as the address wrapperlabelpacking slipand on a bill of ladingwhen in fact it could come from many locations. When the bills of lading are created from a warehouse shipping the productthe origin shows Chicagoeven though it came from a 3rd party warehouse in Los Angeles for example where it was offloaded from a container from China. Companies do that to hide the outsourced manufacturing agent for branding purposes. That is called a “blind” shipment so by the time you match up an invoice to see where it came frometc. it can take a few daysjust like we are starting to see here.

Transportation companies don’t normally like to do thatbut cave in when it means loss of business if others do it. Years ago was not an issuebut not by today’s standards and I can almost bet all of these incidents involved some “blind” bills of lading making it a nightmare to trace. FDA has done their bit on fresh foodbut should really clamp down on this as I don’t think we have seen anything near the end of this. Actually there should be no food or drug products shipped without a full label showing complete originscitystatecountryetc. and no “blind” shipments. Once it has cleared customs and is in a local US warehouseand the bills of lading show a“ blind” origin instead of let’s say a 3rd party bill when the product shipswe have one big mess.”image

The project follows recalls of tainted toothpastepet foodseafood and other products from Chinaas well as a contaminated blood thinner blamed for dozens of deaths in 2008.

About 20 million of shipments of foodmedicinemedical devices and cosmetics are expected to arrive at U.S. ports this yearFDA Commissioner Margaret Hamburg said. That is up from about 6 million a decade ago.

With the growing flood of productsinspectors typically examine less than 1 percent.

Under the new systemborder staff can check products in a computer database that gives a score for the risk level. The score is calculated in part based on whether the maker has a history of recalls and how susceptible the product is to contamination.

High-score products can be set aside for further checks.

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