FDA issued a Warning Letter to a chocolate company highlighting allergen control and other GMP issues. This recall highlights the concern when a supplier has not controlled allergens in their product, and even states that, but the processor uses that ingredient anyway. We are seeing this more often, when a supplier puts a precautionary statement on the ingredient which is purchased....then that issue becomes the purchasing company's issue.
Internally, the company's allergen control program was not implemented properly.
The inspection was started after an allergen complaint where someone reacted to a milk allergen in dark chocolate.
"The inspection was initiated in response to a consumer complaint regarding an allergic reaction and subsequent sampling conducted by FDA, which revealed elevated levels of milk protein in your Ultra Dark Chocolate Amaretto Rainier cherries"
This issue was primarily due to a supplier issue where milk was present in the dark chocolate where the purchasing company did not have milk listed.
"Although milk is not used as an ingredient in your dark chocolate covered nut and fruit products. FDA found elevated levels of milk protein in these products. Further, FDA found elevated levels of milk protein in the chocolate ingredients you use to produce your dark chocolate covered nut and fruit products. These chocolate ingredients do not include milk as an ingredient. Subsequently, you conducted voluntary recalls for the finished product lots associated with the FDA samples."
First, the company did not recognize this supply issue in the hazard analysis, even though the supplier stated it could be an issue.
"Your hazard analysis did not identify the unintentional presence of milk allergens as a hazard requiring a supply-chain applied control in the bittersweet, (b)(4) chocolate you obtain".....The need to consider milk allergens as a hazard requiring a supply-chain-applied control was highlighted by your supplier’s allergen policy indicating the possible presence of undeclared milk allergens. Specifically, your supplier’s policy states that “dark items that do not have milk intentionally added as an ingredient may contain milk from cross contact due to processing on shared equipment.”
Once the company became aware of the issue, they did not revise their Preventive Control Plan.
"You became aware of new information when you received a consumer complaint regarding an allergic reaction to your Ultra Dark Chocolate Amaretto Rainiers (Best By 09/2019) and subsequent test results from a third-party laboratory and FDA. Specifically, you received results from the third-party laboratory indicating the presence of milk protein in the finished product and raw ingredients on September 14, 2018, and September 19, 2018. Subsequently, you received finished product sample results from FDA indicating the presence of milk protein at levels as high as 7000 ppm in your covered nut and fruit products. You also received FDA test results of the chocolate that you obtained from your supplier indicating milk protein levels as high as 4300 ppm. However, after receiving these results, you did not conduct a reanalysis of your food safety plan dated September 12, 2018, to consider whether food allergens are a hazard requiring a supply-chain-applied control."
And they did not determine what activities needed to be in the Supply Chain Preventive Control.
"You did not determine and conduct appropriate supplier verification activities,"
The company had internal issues as well:
4. The company stated they would put a schedule run process in place to run products with specific allergens, but did not follow this run schdule.
"You did not implement a preventive control, as required by 21 CFR 117.135(a). Specifically, your food safety plan dated September 12, 2018, contains the preventive control of “run order of allergenic materials” for the food safety hazard of “food allergens from other products."
5. Mishandling of rework that leads to cross contact
6. Did not conduct visual inspection for allergen control
"our investigators observed apparent chocolate powder and residue on the outside and inside of the air vents for pan #(b)(4) and #(b)(4). These vents are used to blow air over all varieties of chocolates including milk, tree nut, and non-milk, non-tree nut products, which could cause cross contact of milk and tree nuts in products that do not contain milk and tree nut ingredients during the (b)(4) process. And b. On November 7, 2018, our investigators observed apparent chocolate residue on the pouch machine within approximately three inches of open pouches of a non-chocolate product....",
7. Did not document the monitoring of allergen control cleaning processes
"..your food safety plan identified environmental monitoring as a verification activity for your sanitation preventive controls. However, you did not implement an environmental monitoring program."
8. Did not "verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."
9. Employees were not washing hands
10. No backflow prevention devices.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chukar-cherry-company-inc-573446-06272019
Chukar Cherry Company Inc.
MARCS-CMS 573446 — Jun 27, 2019
