An Oregon tofu and soy-based food company covered up its distribution of products that the processor’s own testing found to be contaminated with microorganisms, according to the U.S. Food & Drug Administration (FDA).
Tualatin, OR-based Pacific Nutritional Foods Inc. did not notify FDA about two contaminated products, including one that might have been “injurious to health.”
FDA’s Seattle District Director Charles M. Breen made the allegations against Pacific Nutritional in an Oct. 9, 2009 “Warning Letter” that was made public yesterday.
Breen’s letter, much of which is in bold face type, discloses that a 32-oz Pacific Natural Foods Barista Series Soy Blenders Vanilla and a Select Soy Low Fat Vanilla beverage, both manufactured on Oct. 7, 2008, were contaminated with microorganisms.
The FDA letter says consumers complained in January and February 2009 about “product spoilage.” Pacific Nutritional tested, found the contamination, and withdrew the Soy Blenders from distribution in February 2009.
“FDA was not notified by you of the contamination or the product withdrawal,” Breen writes.
Then in March 2009, company testing found it had a contamination problem with the Low Fat Vanilla beverage. “FDA was not notified by you of the contamination,” Breen again writes.
It is not clear whether the beverage was withdrawn.
FDA’s summary statement is not kind to the Oregon tofu and soy processor, which uses a low-acid cooking method.
“Accordingly, your soy and oat based beverage products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” Breen says in a letter that cites the company for numerous equipment and personnel violations for producing low-acid foods.
According to the company’s website, the 12-year old Pacific Nutritional Foods Inc is a joint venture of Torrance, CA-based Morinaga Nutritional Foods Inc. and Tualatin-based Pacific Foods of Oregon Inc.
It specializes in aseptic processing & packaging products, including tofu and other soy-based products for Morinaga Nutritional Foods, Inc., a subsidiary of Morinaga Milk Industry Co., Ltd. in Tokyo, Japan.
Attempts to reach the company for comment were unsuccessful. Like others receiving FDA “Warning Letters,” it has 15 days to respond to the agency.
Two other “Warning Letters” were released Tuesday, one to a seafood processing facility in Illinois and the other to a dairy in Minnesota.
Bridgeview, IL-based Registry Steaks and Seafood Ltd was warned that its Shell-On-Shrimp, Peeled and Deveined Shrimp, and Cooked Tail-On Shrimp products are “adulterated” within the meaning of the Federal Food, Drug and Cosmetic Act.
The reason is that iced glaze and/or frozen “marinade” glaze containing water, citric acid, and salt is added to increase the bulk or weight of the shrimp. FDA also said the products were “misbranded” under the Fair Packaging and Labeling Act because the weight of the ice glaze is not included.
FDA also found that “Grouper” was in fact Northern Rock Sole, which also amounts to adulterated and misbranded product. In eight inspections between April 28 and July 13, 2009, FDA found seafood processing was occurring in insanitary conditions.
Registry was cited for about a dozen sanitary infractions including not having hot water for washing hands, nor a method for drying them, and the use of toxic chemicals including bleach in seafood processing areas.
Paynesville, MN-based Evergreen Acres Dairy, LLC received a “Warning Letter” for offering an animal for sale that FDA found to be adulterated because of the “presence of neomycin at 31.05 parts per million (PPM) in kidney tissues.” The limit is 7.2 PPM.
The letter takes exception to the way the Minnesota dairy holds and medicates animals, along with its inadequate record keeping.