Recently posted food-related FDA warning letters address alleged violations of juice and seafood Hazard Analysis Critical Control Points (HACCP) regulations, along with Current Good Manufacturing Practice (CGMP) regulations for foods.

FDA’s Los Angeles District Office wrote to Shining Marble Inc. on Sept. 30 to say that violations of both seafood HACCP and CGMP regulations were observed during a July 25 to Aug. 5 inspection of the company’s food and seafood facility in Gardena, CA.

sushituna-406The CGMP problems cited in the warning letter render the company’s fried fish cake sushi roll and Korean rice cake products adulterated, according to FDA, because they “have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

Specifically, FDA stated that the firm did not monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination from insanitary objects, protect food, food packaging material, and food contact surfaces from adulteration and exclude pests from the facility with sufficient frequency to ensure compliance with federal CGMP regulations.

FDA’s inspection found excessive old food residues and grime on the rice roller, equipment joints, and the conveyor belt of the sushi rolling machine, according to the letter.

“The sushi rolling machine was not cleaned and sanitized prior to using,” FDA stated.

Also the sushi cutting machine was “heavily encrusted with old, dried and greasy food residue” on the blades and other areas where the ready-to-eat sushi rolls come into contact with the machine, the agency noted.

Stainless steel food preparation trays were not cleaned and sanitized prior to use, a live roach was seen running onto the side of a shelf next to the sushi processing table near exposed sushi roll ingredients, and other insects were observed on bags of broken rice in the dry storage area, FDA stated.

Other problems cited included not refrigerating ready-to-eat rice cakes that are not shelf-stable, not cleaning and sanitizing the rice cake forming machine prior to use, and an employee contacting food with visibly soiled cloth gloves.

In addition, FDA stated that the firm does not have a HACCP plan for its ready-to-eat Shil La Dang Seaweed Rice Roll to control the food safety hazards of pathogen growth, toxin formations and allergens.

The company’s response on Aug. 23 was found to be inadequate because it did not contain a developed HACCP plan or any supporting documentation for the stated corrective actions that were made, according to FDA’s warning letter. HACCP issues were also the subject of a warning letter sent to Seaquest Seafood Corporation from FDA’s Los Angeles District Office on Oct. 4.

The agency stated that an Aug. 5 inspection of the firm’s seafood importing facility in City of Industry, CA, revealed “serious violations” of the federal rules requiring that all fish and fishery products offered for entry into the United States be processed under conditions equivalent to those required of domestic processors.

Because of these observed violations, FDA stated that the company’s frozen Climbing Perch and frozen Tilapia are adulterated.

Two companies based outside the U.S. were sent warning letters pointing out problems complying with juice HACCP regulations.

Apples in boxes with handsHans Zipperle SpA of Bolzano, Italy, was told via a warning letter from the agency’s office in College Park, MD, that its HACCP plan for apple juice concentrate and apple puree products and a description of practices and procedures for controlling the food hazard of patulin revealed “a continuing serious deviation” from the regulations.

FDA stated that the company’s HACCP plan does not list the food hazard of patulin, which is a mycotoxin produced by a variety of molds and most commonly found in rotting apples.

To the firm’s July 4 response that this risk is managed by “a close monitoring system,” limits defined by European regulations, and client specifications “normally stricter than the law,” FDA responded that these approaches “are not adequate substitutes for control measures” that would normally be included in a HACCP plan.

“Even a small percentage of rotten, moldy, and damaged apples may contain high enough levels of patulin to result in the finished product exceeding FDA’s 50 ppb action level. Therefore, any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production,” the warning letter noted.

Patulin was also mentioned in FDA’s May 4 warning letter to SkyPeople Juice Group Co. Ltd. in Shaanxi, China. The agency wrote that a Dec. 3-4, 2015, inspection of the company’s juice processing facility in Xian had revealed “serious deviations” from the juice HACCP regulations.

“Accordingly, your apple and pear juice concentrate are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the warning letter stated. firm’s revised HACCP plans for “Pear Juice Concentrate, Apple Juice Concentrate” and “Deionized pear juice concentrate, Deionized apple juice concentrate” dated Jan. 20 do not identify the food safety hazard of patulin associated with the apples at the “Receiving raw pear or apple” critical control point, the letter pointed out.

“FDA recommends that apple processors obtain supplier guarantees at receiving (i.e., at your ‘Receiving raw pear or apple critical control point’) for each shipment of incoming fruit specifying that only apples harvested to exclude fallen apples were supplied in the shipment,” the agency stated.

The company’s response and revised HACCP plan were deemed inadequate because the patulin food safety hazard was not identified at the receiving or sorting stage. The agency also took issue with the listed critical limit allowing for a certain amount of rotten fruit.

“FDA recommends culling or trimming all defective apples to control patulin,” the warning letter stated.

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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