A seafood company in Indonesia and a juice manufacturer in California are both on warning from the Food and Drug Administration for serious violations of U.S. law, specifically the seafood and juice Hazard Analysis and Critical Control Point (HACCP) and regulations.

Such violations generally result in companies’ food being determined to be adulterated and therefore possibly injurious to health and not fit for sale. The FDA allows companies 15 working days to respond to warning letters.

Companies that do not respond within the 15-day period, or those who fail to adequately respond, are subject to other enforcement efforts, including food recalls, seizure of products, forced closure or other activities.

There is frequently a lag time of days to weeks before FDA makes warning letters available to the public on its website. The agency posted the following letters on its website in recent days.

PT Mitra T.N., Makassar, Indonesia
In a Jan. 9 warning letter to Director Kamaludin Hasan at the PT. Mitra T.N. seafood company in Indonesia, the FDA described “significant deviations” found during an Oct. 12-15, 2017, inspection at an importer’s facility in California.

Inspectors discovered that Gourmet Fusion Foods Inc. in Culver City, CA, was importing fish from the Indonesian company, but that the foreign company’s HACCP plan for frozen, vacuum-packed tuna was not in compliance with U.S. law.

“During the inspection of the importer, we collected a copy of your HACCP plan entitled ‘Frozen Tuna’, dated March 28, 2016,” according to the warning letter. “Failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of ‘Part 123’ of the plan, renders the fish or fishery products adulterated.

“Accordingly, your frozen vacuum-packaged tuna is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health.”

The FDA warning detailed a number of specific problems with the plan, including these:

• The firm failed to conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points;
• The firm’s HACCP plan for frozen tuna does not list the critical control point or multiple critical control points for unrefrigerated processing to control scombrotoxin (histamine) formation;
• FDA recommends the firm include a critical control point or individual critical control points to monitor the cumulative time and temperature of exposure from when the first fish in the lot is received until the last finished fish from the lot is placed in the freezer;
• Because the frozen tuna product is consumed as sushi and is considered a raw, ready-to-eat product, the company should also identify the food safety hazard of pathogen growth as a reasonably likely hazard;
• For fish delivered refrigerated and not frozen, the FDA recommends that all lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40 degrees F throughout transit; or
• For fish delivered under ice, the FDA recommends that fish be completely surrounded by ice at the time of delivery; and
• FDA recommends that, in addition to segregating and destroying any label stock that does not contain the proper statement and determining and correcting the cause of improper labels, firms also segregate and relabel any improperly labeled product.

The company’s HACCP plan incorrectly lists critical control points for temperature that are not adequate to prevent Clostridium botulinum toxin formation and scombrotoxin (histamine) formation, according to the warning letter.

A C Calderoni & Co. Inc., Brisbane, CA
A C Calderoni & Co. Inc., in Brisbane, CA, is on notice from the FDA because of significant deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act).

“Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

The firm processes juice and drink mixer products, and staff from the FDA discovered “serious violations” regarding the firm’s affected products, according to the March 14 warning letter.

Significant violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation included failure to have a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed and to identify control measures that control those hazards.

“Specifically, your firm informed our investigator that no hazard analysis was done to identify the food hazards reasonably likely to occur in your Royal brand 100 percent lemon juice from concentrate, which your firm manufactures, packages and distributes.”

However, as a juice manufacturer, the firm is required to have done or conduct a hazard analysis to identify all hazards associated with the juice products manufacturer at their facility.

The firm has not identified Listeria monocytogenes and metal fragments as potential hazards. Once identified, they are required to conduct a 5-log reduction process and perform final packaging of their juice within a single production facility operating under current good manufacturing practices. However, the firm stated there is no 5-log reduction done to their Royal brand 100 percent lemon juice from concentrate.

The firm did not monitor the conditions and practices during processing with sufficient frequency to ensure at a minimum, conformance with conditions and practices specifying current good manufacturing practices that include condition and cleanliness of food contact surfaces, prevention of cross-contamination form insanitary objects, maintenance of hand-washing, hand-sanitizing and toilet facilities, protection of food, food packaging material and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals and control of employee health conditions.

“Specifically, during the inspection you informed the investigator that you do not maintain sanitation records for documenting the monitoring of all eight key areas of sanitation. You only maintain records for water safety testing obtained annually from the City of Brisbane and monthly pest control records from your contracted pest control firm,” according to the warning letter.

Additionally, the firm’s juice equipment is cleaned and sanitized only once a month. It is flushed only with hot water before daily production runs. “Daily equipment cleaning and sanitizing is essential to prevent contamination by microorganisms that pose a significant health hazard,” the letter stated.

The FDA added that it is the firm’s responsibility to ensure that their sanitation procedures include that all eight areas and are completed, monitored and recorded in accordance with the regulation.

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