For a time, canned black beans from Japan’s Sanuki Kanzume Co. near Yurihonjyo-shi west of Tokyo were prevented from entering the U.S. because the plant was not registered for low-acid or acidified food manufacture.
Inspectors from the U.S. Food and Drug Administration (FDA) returned to that low-acid canned food facility last Nov. 18 and 19. They said they found serious deviations from the low-acid canned food regulations imposed by the U.S. on importers.
By not adhering to those regulations for products offered for sale in the U.S., FDA said the Japanese company’s low-acid canned food products are considered “adulterated” under U.S. federal law “…in that they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”
FDA said it presented the company with a Form 483 report following its inspection and received a written response last Nov. 30. But FDA did not think the response adequately addressed all its concerns.
In a March 29 warning letter to Sanuki Kanzume, the agency again threatens to refuse entry to its low-acid canned food products. FDA reminded the business that its products may be detained without any need to put them through physical inspection. Such a decision could simply be included in FDA’s Import Alerts, and the low-acid canned foods could not enter the U.S.
Among FDA’s current concerns about the food facility are:
— the lack of a “qualified scientific authority” for making changes in the scheduled process
— the size of the can used for “Mushrooms Nameko (Whole) in Water Salt Added: Nameko Mizuni,” which the agency says is not an option under the company’s current processing schedule and raises questions about venting and temperatures
— the failure to measure and record initial temperatures of the contents of containers to be retorted
— the vertical still retorts lack of a large bleeder
— the teardown procedures and failure to chlorinate
FDA gives foreign importers 30 working days to respond to warning letters. It urged Sanuki Kanzume to respond with written documentation that can assist the agency in evaluating the corrections.
Sanuki Kanzume previously was blocked from importing to the U.S. in 2003 and 2008, according to FDA records.
Low-acid canned foods are products like green beans, mushrooms, and tuna fish. They are packaged in hermetically sealed containers, have a pH greater than 4.6 and a water activity greater than 0.85.
Acidified foods are low-acid foods to which acid is added to reduce the pH to 4.6 or below.
Some examples of acidified foods are pickles, pimientos, and marinated artichokes. Acidified foods must also have a water activity greater than 0.85 to be included under the regulations.