"Angelica sinensis, commonly known as dong quai (simplified Chinese: 当归; traditional Chinese: 當歸) or female ginseng, is a herb belonging to the family Apiaceae, indigenous to China. Angelica sinensis grows in cool high altitude mountains in China, Japan, and Korea. The yellowish brown root of the plant is harvested in the fall and is a well-known Chinese medicine which has been used for thousands of years."[Wikapedia]
"According to CDC, as of July 7, 2021, 20 people from 4 states have been infected with the outbreak Salmonella serotypes. Four of the same Salmonella serotypes (Urbana, Leiden, Vinohrady and Chester) were also found in an environmental swab taken from your vegan cashew brie (b)(4) during FDA’s inspection, your vegan cashew brie varieties, and/or your incoming cashew pieces used to manufacture your vegan cashew brie products. CDC and FDA have determined, based on the epidemiologic and laboratory evidence, that the RTE vegan cashew brie products produced at your facility are the likely source of the multi-state Salmonella outbreak."The company felt that receiving a COA for the cashews was sufficient, but without the supplier actually controlling Salmonella, a test will not determine low levels of contamination. And with inadequate cleaning as identified in the Warning Letter, those low levels of Salmonella can be disseminated in the product.
"The COA provided appears to be for a different lot of cashew pieces than the subject lot referenced above from which FDA isolated Salmonella Urbana ((b)(4) vs (b)(4)). Further, your response references FDA‘s draft guidance2, “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals,” in regard to use of a COA. That draft guidance states that “[t]esting of . . . the food produced by the supplier may be an appropriate supplier verification approach if such testing provides meaningful results relating to control of a hazard requiring a control.” (Emphasis added). However, your supplier was not controlling the hazard of Salmonella in the raw cashews; therefore, it was not appropriate for you to rely on testing (as reported on the COA) to address the Salmonella hazard. Because the hazard of Salmonella was not controlled by your supplier, it was necessary for you to control the hazard."
