Four out of five recently posted food-related warning letters from the U.S. Food and Drug Administration went to companies based in other countries. Three involve seafood HACCP issues, while the other two address food labeling/misbranding problems and drug residues, respectively.

FDA wrote to Tentay Food Sauces Inc. on April 19 to say that violations of seafood HACCP regulations were identified during a Sept. 8-9, 2015, inspection of the firm’s seafood processing facility in Navotas, Philippines.

Tentay products copyThe agency specified that a hazard analysis for each kind of fish and fishery product must be conducted. The firm’s HACCP plan for its fish sauce doesn’t list the food safety hazard of Clostridium botulinum toxin formation in either the raw material used to make the product or in the finished product, according to the warning letter.

Additional problems mentioned included no listed critical control points for storage prior to unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. Other issues concerning the firm’s fish-to-salt ratio were also noted.

FDA acknowledged the company’s responses emailed Oct. 28, 2015, and Jan. 5, 2016. However, the documentation included in those responses was found to be inadequate because the agency could not be sure that the cause of the cited deviations would be corrected.

Keshodwala Foods in Veraval, Gujarat, India, was sent a warning letter July 7 responding to HACCP-related documentation the company had submitted to FDA.

The firm’s process flow chart for scombrotoxin (histamine) forming fish, a process description, a hazard analysis and a HACCP plan for scombroid (histamine-forming) fish emailed to the agency April 5 had “serious deviations” from the requirements, according to the letter.

These deviations included no listed critical control points of raw material storage, in-process iced storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation, FDA stated.

“As a primary processor receiving the fish directly from the harvest vessels, FDA recommends that your firm’s HACCP plan list critical limits for harvest vessel records, or histamine testing, and the internal temperature of a representative number of the largest fish in a lot, at the time of off-loading from the harvest vessel to ensure that appropriate harvesting and onboard practices are used onboard the harvest vessel,” the warning letter read.

On July 28, FDA sent a similar warning letter to Jin Tzer Marine Products Co. Ltd. in Wujie Township, Taiwan, to say that the company’s HACCP plans and supporting documentation emailed to the agency April 26 did not comply with seafood HACCP regulations.

Specifically, the firm’s HACCP plans entitled “Frozen Raw Material HACCP plan (dolphin fish pieces, fish bar)” and “Frozen fish pieces, fish bar” were found inadequate to control scombrotoxin (histamine) formation, according to FDA.

“You should monitor the length of time that the scombrotoxin (histamine) forming fish are exposed to unrefrigerated conditions from when the first fish in a marked batch is exposed to an ambient temperature above 40°F (4.4 °C) until the last fish in the batch is placed in the freezer,” the warning letter stated.

FDA wrote to Fu Fa Flour Food Enterprise Co. Ltd. in Taoyuam, Taiwan, on May 9 to point out food labeling and misbranding violations the agency identified during an inspection of the facility on Sept. 14-15, 2015.

The label for the firm’s “Dry Noodle Spinach Favour” product was collected during that inspection, FDA noted.

“FDA has reviewed the labeling for this product and, based on our review, we have concluded that this product is in violation of the food labeling regulations … ,” the warning letter stated.

The company’s responses emailed to FDA on Jan. 28, Feb. 2, Feb. 5, Feb. 10 and March 15 concerning labeling corrections and color certification information were evaluated and found wanting.

FDA wrote that the product label states that it contains Sunset Yellow FCF and Brilliant Blue FCF, which were not certified as FD&C Yellow No. 6 and FD&C Blue No. 1, respectively, and are therefore unsafe.

Other problems mentioned in the warning letter involve labels not bearing the common or usual name of each ingredient, an inappropriate format for the nutrition facts information and serving size, and other issues regarding fat calories, sodium content and allergens.

Finally, FDA wrote, “We question whether the statement of identity, ‘Dry Noodle, Spinach Favour’ should be ‘Dry Noodle, Spinach Flavor.'”

Cattle_nov_406x250Lorch Farms Inc. was sent a warning letter dated Oct. 6 stating that an investigation on Sept. 14-15 of its cattle feeding operation in Harris, IA, revealed that an animal had been offered for sale for slaughter as food which was adulterated under the Federal Food, Drug, and Cosmetic Act.

The investigation was conducted by officials with the Iowa Department of Agriculture and Land Stewardship who were representing FDA, the letter noted.

On or about June 28, a steer shipped from Lorch Farms was slaughtered at a slaughtering facility, according to the warning letter. Analysis of tissue samples from this animal identified the presence of 3.47 ppm of desfuroylceftiofur in the kidney tissue. However, the tolerance level for residues of this drug in the edible tissues of cattle is 0.4 ppm.

Other problems cited in the warning letter were: No adequate system to make sure medicated cattle have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues, failure to maintain treatment records, failure to properly segregate treated animals and failure to verify treatment of cattle before shipping.

Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.

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