FDA warnings: Traceability, drug residues, juice hazards

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Warning letters recently posted by the Food and Drug Administration addressed a variety of violations at a food company in China, a dairy in Iowa and a juice producer in Connecticut.

Companies have 15 days to respond to FDA warning letters.

Weifang Sunwoo Foods Co. Ltd.
In a Sept. 21 warning letter, the director of the Office of Compliance for FDA’s Center for Food Safety and Applied Nutrition notified owner and general manager Zhang Fengguan that the company in Shandong Province, China, has “serious deviations from the Emergency Permit Control regulation” for its acidified foods.

Specifically, inspectors noted on April 26-28 that the company’s pickled radish products were not being processed long enough or at proper temperatures. Improper processing times and temperatures were also observed for the company’s seasoned sweet ginger and seasoned burdock, according to the warning letter.

Also, the Chinese food producer was cited for failing to have required traceability information and documents for its products.

“Your firm failed to adequately mark each container in accordance with 21 CFR Part 114.80(b). Specifically, your containers are not marked with a code identifying establishment where packed, product contained, year, date and packing period,” according to the warning letter.

“Your firm failed to maintain required records in accordance with 21 CFR Part 114.100(e) for a period of three years from the date of product manufacture. Concerning our request for temperature recording data records for a lot of Burdock manufactured on 4/13/2015, your firm replied that you keep computerized records for less than a year on a computerized file.”

Bear Creek Dairy LP
In a Nov. 21 warning letter, the director of the FDA’s Kansas City district office notified the owner, Johanes A. Boelen, that the dairy cow operation in Brooklyn, IA, violated federal law by selling an animal for slaughter as food that contained a “new animal drug that is unsafe…”

On June 14 Bear Creek Dairy sold a cow that was slaughtered the following day and then tested by the USDA’s Food Safety Inspection Service. The animal’s tissues had 0.883 parts per million (ppm) of Flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle.

The cow’s tissues also had 0.54 ppm of Desfuroyceftiofur in the kidney. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle.

In addition to the excessive drug residues, federal inspectors noted that the dairy holds “animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Also you failed to properly maintain an inventory system for determining quantities of drugs used to medicate your livestock.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).”

Stay Fresh Foods LLC
The director for FDA’s New England district office notified founder and managing director Amy Lawless in a Nov. 21 warning letter that inspectors found the company in violation of federal law related to juice production during an Aug. 2-12 inspection of its production facility in Meriden, CT.

“This inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation – Title 21, Code of Federal Regulations, Part 120, 21 CFR Part 120,” according to the letter.

The FDA warning states that responses from Stay Fresh Foods dated Aug. 25 and Sept. 20 were inadequate.

“(You) indicated that you will require your customers to sign a ‘quality questionnaire’ that confirms they have a HACCP plan that accounts for any appropriate hazards and that their plan is validated annually,” the FDA warning letter states.

“You also state that your firm has no responsibility for formulation or the production process of your customers. Your responses are inadequate because your firm is considered a juice processing facility subject to the requirements in 21 CFR Part 120, which includes having control measures in place to achieve a consistent 5-log reduction of the pertinent microorganism.”

The FDA warning also states that the Stay Fresh Foods process to kill the pathogen that causes botulism poisoning have not been proven effective.

“… your firm has not validated, as required by 21 CFR 120.11(b), that your processes — refrigeration and the high pressure processing (HPP) — achieve the requisite 5-log reduction to control Clostridium botulinum,” according to the warning letter.

“FDA has information to support that HPP coupled with refrigeration are not validated processes that can reduce the spores of Clostridium botulinum in low-acid juices. In fact, non-proteolytic spores of Clostridium botulinum can grow and produce toxin in low acid juice even under refrigeration temperatures.”

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