Tofu firm stops operating after FDA findings

By Joseph James Whitworth contact

- Last updated on GMT

FDA inspected the facility last year, in 2013, 2011 and 2010.
FDA inspected the facility last year, in 2013, 2011 and 2010.
Fong Kee Tofu has agreed to stop operating at least until the US Food and Drug Administration (FDA) finds improvements.

A consent decree of permanent injunction was filed against the firm, Yan Hui Fong, co-owner and CEO and Jen Ying Fong and Suny Fong, co-owners and corporate officers, to prevent the distribution of adulterated tofu and other soy food products, said the Department of Justice (DOJ).

DOJ filed a complaint in the Northern District of California​ late last month at the request of the FDA.

Defendants’ agreement

The defendants agreed to settle the litigation and to be bound by a permanent injunction that requires it to cease all operations. 

If they wish to resume manufacturing and distributing food, the FDA first must determine that manufacturing practices have come into compliance with the law.

The complaint alleges the defendants have a history of processing soy food products under insanitary conditions.

The company receives, prepares, processes, manufactures, labels, packs, holds and distributes soy food products including soy drinks, firm tofu, soft tofu, fried tofu balls (oil bean cake) and soybean cake.

Previous FDA inspections

FDA has inspected the facility last year, in 2013, 2011 and 2010.

Inspectors observed pigeons on top of plastic-wrapped raw soybean pallets and insects flying around the area used to process firm tofu in in April 2014.

The loading dock door was kept open at several times during the day allowing pests into the site, said the complaint.

“This is a repeat observation from the January 2013, December 2011 and November 2010 inspections. This observation was also noted in the warning and untitled letters sent to the defendants in 2012 and 2011.”

Employees were seen using utensils that had not been properly sanitized in food production and packing tofu without washing or sanitizing their hands after coming into contact with insanitary objects.

Residue was found on equipment used in processing tofu even after cleaning, said the complaint.

Suny Fong promised corrections such as instructing employees to wash hands and observing them for a month, according to an email dated April 29, 2014.

However, the compliant said this does not adequately address the violations as they are only partially referenced and does not mention labelling deficiencies.

Yan Hui Fong, Suny Fong and Jen Yin Fong are Fong Kee Tofu’s corporate officers with the authority and responsibility for preventing and correcting violations of federal law at the company.

Joyce Branda, acting assistant attorney general of the Justice Department’s Civil Division, said Fong Kee Tofu was repeatedly informed sanitation practices at its facility were deficient.

“The failure to make sure that its facility was operating under sanitary conditions could be a serious risk to the public health and needed to be remedied.”

Related topics: Food Safety & Quality

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