Warning Letter Issued to Company for Not Verifying That Corrective Measures Worked

FDA issued a Warning Letter to a California company after that company did not adequately respond to a 483 Report issued during inspection.  The inspection was performed after the company's product was involved in a Salmonella outbreak.  During the inspection, Salmonella was found during FDA environmental sampling and this was included as a finding on the FDA 483 that was issued.  From the FDA website: "An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C)".  The company is then expected to send a written response to the 483 report.  "Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously."
When a company does not properly respond and/or take appropriate corrective action, FDA will issue a Warning Letter.  From the FDA website: "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration's (FDA's) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10.) The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law."

As we have seen in a number of other recently issued Warning Letters (Examples 1, 2, 3, 4) companies are failing to properly address the elements of corrective action.  As with this case, measures are taken, but the company fails to verify that those measures have worked.  From this report: "However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak."   The verification that corrective measures worked is especially important after the company has had an outbreak and/or was found to have pathogen contamination issues.

 FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524491.htm
WARNING LETTER
 October 7, 2016
 

Colors and Printing on Food Packaging

An article in Food Safety Magazine, Colorants in Food Packaging: FDA Safety Requirements (Oct/Nov 2016), reviews the FDA safety requirements of food packaging colors and printing.   In summary, "The rules of thumb for determining the regulatory status of a pigment or dye are as follows: A substance that colors the food, even if it is in a packaging material, is a color additive and may be used only as permitted by an applicable FDA color additive regulation. Substances that color only a packaging material, and do not impart color to the food, are regulated as food additives if components of the substance are found to migrate into food. No premarket clearance by FDA is required, however, if the substance is not reasonably expected to become a component of food, is GRAS or is included on the list of “pre-1958 colorants.”

There are always questions about printing on the primary packaging and what is the concern.  So, the primary question is whether that printing material can migrate to the food.  If it can, then that color needs to be approved for use.

Blue Bell Expands Recall After Supplier Expands Recall of Cookie Dough, Blue Bunny and Others Also Issues Recalls

Blue Bell is expanding its recall of cookie dough ice cream after its ingredient supplier of cookie dough expanded its recall for Listeria.   Just over two weeks ago, Blue Bell issued a recall for 5 lot codes of two flavors that contained the cookie dough ingredient.  That recall now includes all product made from February 2, 2016 through September 7, 2016.
Along with this, Blue Bunny is recalling its Hoppin' Hollidoodle ice cream because it also contains the suspect cookie dough.

 We have come to expect expansions of recalls when there is Listeria contamination issues.  These recalls get expanded because the facility finds that there are underlying issues which indicate that Listeria could have been around for some time in the facility.

Other recalls affected by this supplier of cookie dough.

Chocolate Shoppe Ice Cream Company Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk

Publix Recalls Publix Premium Chocolate Chip Cookie Dough Ice Cream Due To Possible Listeria monocytogenes Contamination From Aspen Hills, Inc. Cookie Dough Pieces

Nutrisystem Retail Division Voluntarily Recalls One Product Containing Chocolate Cookie Dough Pieces Purchased From Third Party Supplier Due To A Possible Health Risk
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524749.htm
Outside Supplier Aspen Hills Expands Cookie Dough Recall; Blue Bell Recalls All Products Made With Aspen Hills Cookie Dough Due To Potential Health Risk
For Immediate Release
October 10, 2016

NY Taco Chain Linked to Over 150 Cases of Foodborne Illness

A NY taco chain is being linked to over 150 people becoming ill.  Cases have occurred in two counties  and it appears that a 'handful' of the Mighty Taco locations may be involved.  The symptoms are nausea and vomiting.  After removing suspect food, including refried beans, the number of cases looks to be subsiding.

An update was provided on 10/20/16.

WKBW News
http://www.wkbw.com/news/142-reported-illnesses-after-mighty-tacos-refried-beans-caused-concern-in-erie-county
142 reported illnesses after Mighty Taco's refried beans caused concern in Erie County

Cesar Brand of Pet Food Recalled for Small Plastic Pieces

Mars is recalling a limited number of Cesar Brand Filet Mignon Flavor wet dog food products due to small pieces of plastic that may be a potential choking risk.  According to the release, the small pieces of plastic entered the food during the production process.

Mars Corporate News Release
https://www.cesar.com/notice#

Micro Greens Recalled in CO for Salmonella Positive Sample

A Colorado company is recalling Organic Micro Greens sold at Whole Foods.  The recall was issued after FDA tested and found Salmonella is a sample of the product.

So what are microgreens?  They are very young plants of various vegetables, such as kale, spinach, beets, lettuce, etc, that are 7 to 14 days after germination.  Similar to bean sprouts, although sprouts are harvested 2 days after germination, so microgreens in comparison will have leaves and roots whereas sprouts will not.   However like sprouts, micro greens can be a higher risk for organisms like Salmonella.  The reason is that the conditions for growth of the micro greens will support organisms such as Salmonella.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524638.htm
Osage Gardens Inc. Recalls Osage Gardens Organic 2oz Micro Greens Because of Possible Health Risk
For Immediate Release
October 7, 2016

Chicken Salad Linked to Salmonella Outbreak in WA

Costco Chicken Salad, purchased on August 26, August 31 and September 2, 2016 in one Washington state Costco store may be linked to a Salmonella outbreak.  While the product is past the expiration date, concern would be for anyone who may have frozen the product and still have it in the freezer.

The concern still has to be how the product became contaminated.  Was the chicken undercooked?  Or was it a case of cross contamination after cooking?


FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2016/pha-100916
FSIS Issues Public Health Alert for Chicken Product Due to Possible Salmonella Contamination

Limited Amount of Lunchables Recalled Due to Allergen Mislabeling

Kraft Heinz is recalling a limited amount of Lunchables product due to a mismatched label that resulted in allergens not being declared.  According to the release  "Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-093-2016-release
Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers Product Due to Misbranding and Undeclared Allergens
Class I Recall 093-2016
Health Risk: High Oct 9, 2016

Drumstick Sundae Cones Recalled Due to Positive LM Product Contact Surface

Nestle is recalling its ice cream treat, Drumstick cones, from Best before June 2, 2017 to June 19, 2017 after testing found the food contact surface positive for Listeria monocytogenes.  No product had tested positive.  No illnesses have been reported.

In the notice, it states "The products impacted by the voluntary recall were put into distribution inadvertently."  This may suggest that the product was on a test-and-hold and was released prior to the finalized test results.   Even though the positive was found on a surface that is classified as product contact, there is a risk that the product may have been contaminated as well, at least one has to consider it.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm524634.htm
Nestlé USA Initiates Voluntary Recall Of Nestlé® Drumstick® Club 16 Count Variety and 24 Count Vanilla Pack Due to Possible Health Risk
For Immediate Release
October 7, 2016