A low-acid canned food facility located in Chao Zhou, Taiwan, has “serious deviations” from the low-acid canned food regulations, the U.S. Food and Drug Administration (FDA) says.
United Taiwan Corporation owns the facility, which produces Sweet Red Beans for export to the United States. Compliance with the regulations is mandatory for “products offered for entry to the United States,” FDA says.
“Accordingly, your product, Sweet Red Beans, is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have rendered injurious to health,” says a Dec. 2 FDA warning letter to United Taiwan.
FDA inspectors visited the facility last Aug. 5 and 6.
“The inspection resulted in FDA’s issuance of an FDA-483, Inspection Observations, listing deviations found at your firm at the conclusion of the inspection,” the warning letter said. “Your firm provided a response to the FDA-483 via e-mail on Aug. 16, 2010, and adequately addressed the Current Good Manufacturing Practice deviations. However, upon further review of the inspectional findings and documentation provided in your firm’s response, we have the following concerns with regard to your LACF products:”
— the scheduled process for Sweet Red Beans, including the retort.
— the scheduled process for Sweet Red Beans for process temperature.
— the parameters for the scheduled process do not match those typically filed.
FDA asked that United Taiwan file a revised schedule process on the agency’s online database. It gave the Taipei-based company 30 working days to respond to its other concerns.
If United Taiwan does not respond, FDA said it may take further action, including refusing to admit the company’s low acid canned food products to the U.S. market. It reminded the company that it could detain products from entry to the U.S. without the need to physically examine them.
FDA’s regulations for low-acid canning are intended to prevent deadly botulism from being produced.