The latest posted warning letters from the U.S. Food and Drug Administration (FDA) were sent to a seafood processor in California, an airline meal caterer in WA, a dairy farm in NY, and a fish processor in Thailand.
On May 30, 2014, FDA’s San Francisco District office in Alameda, CA, wrote to Roundman’s Smokehouse in Fort Bragg, CA, to note that agency inspectors had checked the company’s seafood processing facility on Feb. 25 and 27, 2014, and found “serious violations” of federal seafood HACCP regulations.
“Accordingly, your refrigerated vacuum packaged ready-to-eat smoked albacore tuna and sockeye salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the letter stated.
FDA stated that monitoring plans at the brining and cooler storage points were inadequate for controlling pathogen growth and toxin formation and that sanitation conditions and practices needed to be monitored more closely. FDA also acknowledged emailed responses from the company about corrective actions and indicated that officials would verify these corrective actions during the next facility inspection.
LSG Sky Chefs Inc., of Seattle, WA, received a letter from FDA’s Seattle District office in Bothell, WA, dated May 29. LSG Sky Chefs, which is owned by German airline Lufthansa, was informed in the letter that inspectors had visited the airline catering facility in Seattle on Feb. 26, 28 and March 3, 2014, and, after reviewing the labeling of on-board meals for purchase, found them to be misbranded.
Specifically, FDA’s letter stated that some sandwiches and fruit and cheese plates the company prepared for United, American, Alaska and Virgin America airlines did not list on the food package (or had incompletely or inadequately listed) the following allergens: wheat, milk, egg.
FDA noted LSG Sky Chef’s response that it would itemize the allegens in any food for purchase on the boarding bill, but the agency indicated that was “not adequate as the allergen information and ingredient statement must be placed directly on the package.”
Luce Dairy Farm of Varysburg, NY, received a warning letter dated May 29, 2014, from FDA’s New York District office in Jamaica, NY, after selling a calf for slaughter in July 2013 that FDA officials considered adulterated because of unacceptable levels of drug residues in its tissues.
Analysis of tissue samples revealed 5.87 parts per million (ppm) of sulfamethazine in the liver tissue and 4.06 ppm of sulfamethazine in the muscle. FDA has not established a tolerance for residues of sulfamethazine in the edible tissue of bob veal calves.
In a letter dated May 15, 2014, Southeast Asian Packaging and Canning Limited of Samut Prakan, Thailand, was told by FDA’s College Park, MD, office that the firm’s fish and fishery products were not in compliance with seafood HACCP regulations.
FDA stated that the company needed to make sure that fresh fish were not held for more than four hours between delivery from a vessel and processing in order to avoid scombrotoxin formation. There were also questions noted about precooking and internal temperature monitoring of pouch-paced tuna related to Staphylococcus aureus growth and toxin formation.
The letter further stated that, barring an adequate response from the company, FDA may refuse admission into the U.S. of imported fish or fishery products, including placing them on detention without physical examination upon entry.
FDA’s Baltimore, MD, district office wrote to Fiber Foods Inc. of Norfolk, VA, on May 13, 2014, to state that, after an agency inspection from March 31-April 2, 2014, a review of product labels found that Yellow Wonton Wrapper and Egg Noodle products are adulterated and misbranded because they bear or contain a color additive (FD&C Yellow No. 5 and No. 6) which is not listed in the ingredient statement.
FDA further stated that the company’s Yellow Wonton Wrapper, Egg Roll Wrapper, Egg Noodle, and Chinese Yock-A-Mein Wheat Noodle products are misbranded because the label fails to declare the presence of egg and wheat, which are major food allergens.
The letter noted that FDA investigators had observed a series of products being manufactured and then scraps from each product being reworked into the subsequent product. For example, the wonton wrappers with egg were made first and this was reworked into egg roll wrappers, and so on.
“Since the rework was intentionally added to each of the foods made after the wonton wrappers, the ingredients in the rework are considered ingredients in any foods made from them,” the letter stated.
Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.
