It was a busy month of June for the Food and Drug Administration (FDA), the government agency responsible for inspecting facilities to make sure that they are following proper food safety standards. The FDA usually handles inspections and recall announcements on a daily basis. By and large, any recall announced by the FDA is voluntarily initiated by the recalling company. On some occasions, however, the FDA is forced to take action against a company. This action may come in a few different forms, including warning letters, injunctions, and even product seizures. The FDA issued four warning letters and one injunction between May 31 and June 30. The FDA also seized products from a warehouse, which is a fairly rare move from the agency.

May 31 – Summit Nutritionals

The FDA’s busy month began on May 31, when it sent a warning letter to Summit Nutritionals International in Branchburg, New Jersey. The letter cited issues in several different inspections done by FDA officials. While no glaring issues that would lead to a pathogen contamination were found, there were several labeling issues pointed out regarding several different products. Their Hydrolyzed Salmon Collagen Powder 90% Protein was said to be falsely labeled, as the actual product contained in the packaging was Hydrolyzed Gelatin. The labels also proclaim that the product is “Proudly Made in The USA”, while the manufacturers’ label for the Hydrolyzed gelatin declares that it was produced in China. These issues may not be limited to salmon collagen products and might extend to porcine, bovine, and chicken collagen products also made by the company. It was these issues with labeling, in addition to some record-keeping problems, which caused the letter to be sent. As per regulations, the company was given 15 days to respond to the warning letter.

June 7 – Pressure Safe

One week later, the FDA sent a warning letter to Pressure Safe, LLC. The Portland, Oregon-based company processes juice products in a high-pressure environment. FDA inspectors visited the facility from February 13 to 15, and from February 22 to 23, 2017. The company failed to have an adequate plan of action in order to prevent product adulteration. The juices produced at the facility were prepared, packed, or held under insanitary conditions. The FDA voiced concerns that the processes used by Pressure Safe did not prevent the growth of Clostridium botulinum. The low acid 100% juice products are put through a high-pressure processing, but this process is not enough to prevent C. botulinum growth. In fact, C. botulinum can grow in cold environments, as well as in low acidic environments. Even in high acidic products, though, the FDA has stated that there are not enough safeguards in place to prevent pathogen growth. Pressure Safe also failed to fix issues found by prior FDA inspections. These issues are what led to the warning letter, which the company had 15 days to respond to.

June 14 – Lopez Tortilla Foods

June 14 came with another warning letter. This time the letter was sent to Lopez Tortilla Foods, Inc. and listed quite a few problems with the facility. The FDA inspected the Dallas, Texas facility between January 24 and January 27. The nine specific problems listed by the FDA started with the fact that the company failed to ensure that pests, specifically rodents, were properly prevented from being in the facility. Rodent feces were found on top of final product in three separate areas. In addition, the FDA discovered holes in four different roll-up bay doors, which could potentially be ingress points for rodents.   Rodent bait pellets were found directly under finished products, leading the FDA to cite issues with the proper storage of completed products. Food production equipment was found to be not cleaned as often as they should be, which is the same observation made in 2014 and 2011 inspections of the same facility. The firm was also found to be in violation of regulations requiring utensils and other equipment to be sanitized regularly. Failure to adequately drain areas that may contribute to food contamination was also cited. The firm failed to provide enough space to store equipment and, further, failed to properly store the equipment. Lopez Tortillas also failed to provide adequate hand washing facilities, and thus was also cited for employees not washing their hands enough. The FDA also stated that these are not necessarily all of the violations found during the inspection, and the company has 15 days to respond to the letter.

June 19 – Goff Seafood

The last of the warning letters sent in June came on June 19. This letter was sent to the Dry Prong, Louisiana-based Goff Seafood. Inspectors visited the facility between May 22 and May 25. There are several things pointed out in the warning letter. All of which, when considered together, led to the sending of the letter, as the FDA says they point towards Goff Seafood’s products being adulterated. The company did not provide sufficient storage for equipment used in the food production process. There was also a failure by the firm to provide adequate hand washing stations, which could lead to cross-contamination. The freezers where finished product was stored did not have a thermometer, making it difficult to verify that the products were being kept at the correct temperature. Surfaces that food comes into contact with were not properly sanitized. Also, the plumbing and the freezers were not adequately maintained.

June 20 – Professional Warehouse

The very next day the FDA, with the aid of the United States Marshal Service, seized products being stored at a warehouse in Minnesota. Professional Warehouse, based in St. Paul Minnesota, had about $73,000 worth of products. The reason for the seizure, as stated by the FDA, was that there was widespread vermin activity present in the warehouse. Like in many other cases of action taken by the FDA, the action only comes as a result of repeated failings to meet FDA standards. For more information about that seizure, click here.

June 30 – Smokehouse of NY

In an uncommon move by the FDA, although not as uncommon as product seizure, the FDA announced a permanent injunction against the Smokehouse of NY. The company, based in Mamaroneck, New York, is no longer allowed to produce any products until the environment in the facility is brought up to FDA standards. The injunction was filed because of a constant Listeria monocytogenes contamination. Inspections this year found widespread Listeria contamination, including on areas that come into contact with food. Poor sanitation practices were also observed. Although no illnesses have been connected to the widespread Listeria contamination, there is still reason to believe that the products made by Smokehouse of NY could potentially be contaminated with Listeria bacteria. This is not this company’s first run-in with the FDA. The Smokehouse was issued a warning letter back in 2011 because of Listeria contamination. Recalls were issued in 2013 and in 2017 for smoked fish. In both cases, Listeria contamination was responsible for the recall.

Such an active month can be seen as concerning, as it points towards the fact that contaminations and potential adulterations may be happening at an increased rate. One thing that is worth pointing out, though, is that the fact that there was such an active month means that the system is working. The FDA has not always had the ability to take meaningful action against companies who do not meet the standards of food safety regulations, and the announcements that action is taking place against potential issues should help consumers eat a little easier.

Sources:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562515.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565463.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564181.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564513.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564197.htm

https://www.fda.gov/Safety/Recalls/ucm552764.htm

http://wayback.archive-it.org/7993/20170112153118/http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2013/ucm249131.htm

http://wayback.archive-it.org/7993/20161023100738/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm271709.htm