FDA update January 3, 2012

Food sandwich manufacturing company in the Chicago-area has agreed to stop producing and distributing the ready to eat sandwiches

The FDA recently posted (Dec. 22, 2011) that a food sandwich manufacturing company in the Chicago-area had agreed to stop producing and distributing the ready to eat sandwiches and produce as part of a consent decree filed in the US District Court of the Northern District of Illinois.

This consent decree was issued after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility this action was  prompted by FDA investigator repeatedly found unsanitary conditions favorable to Listeria growth and a  history of violations (the company was issued a warning letter in Nov. 2002 and then in April 2011).

The terms of the decree would also require the company to hire a sanitation expert to help establish an effective sanitation program to comply with FDA regulations and to eliminate Listeria contamination from company facilities.

The government’s complaint, filed by the U.S. Department of Justice on December 22, 2011, describes the company’s history of operating under unsanitary conditions and Listeria monocytogenes contamination in the processing facility.  It also outlines the company’s failure to comply with Current Good Manufacturing Practice and seafood Hazard Analysis and Critical Control Point regulations.

Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes causes fatal infections in young children, older people, and in those with weakened immune systems. Healthy people may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea.  Listeriosis can also cause miscarriages and stillbirths.

“FDA took these aggressive actions because this company continued to violate current good manufacturing practice regulations and allow for conditions that could affect the health of consumers,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs.

No illnesses have been reported to date from the company’s products.  Illnesses or adverse events related to use of these products should be reported to the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.  The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

This FDA update was not being written to notify you of this action but the length of time it took the FDA to act to “protect the public health” (as described in its mission in the preceding paragraph).

How can the FDA and especially the FDA commissioner claim that they are protecting the public health when in 2002 they issued a warning letter and then another one in April 2011 with potential health hazard concerns and it takes the FDA 8 months to get the company to sign a consent decree and stop operations till they clean up.

The FDA Commission promised much faster response to a lack of compliance.  It is not her fault that the FDA did not take any action after the 2002 W/L, she was not with the FDA at that time.  But she did promise that the public health would be protected with fast action to address potential problems.  As a matter of fact, the company was inspected in January 2011 and it took the FDA 3 months to send out the warning letter then another 8 months for the consent decree. The company was allowed to operate for almost a year without FDA action to force the company to take the proper action to prevent potential food contamination.  This would not appear to be in the public interest.

So, why did it take so long for the FDA  to send out the warning letter after the inspection (the inspection was finished on Jan. 21, 2011 after an almost 3 week audit and the warning letter was finally sent out on April 20, 2011, almost 3 months after the 483 was issued.)

The reason it takes so long for the FDA to take action is because the FDA is a bureaucracy that has to follow its guidelines in making a determination on when an action can be taken.  And, this takes time.  Unfortunately, the FDA Commission’s good intentions could not be followed up with swift actions to protect the public.

Too discuss the FDA time frames for their legal actions, email us at info@mdiconsultants.com and ref: time frames