Three seafood companies that export seafood to the United States on notice from the Food and Drug Administration for violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, in addition to several other U.S. food safety laws.

The FDA sent the warning letters to the companies in Latvia, Portugal, and Taiwan in April, May, and July. The agency posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunctions.

SIA Piejura, Avoti Liepajas Aprinkis, Latvia
SIA Piejura in Avoit Liepajas Aprinkis, Latvia is on notice from the FDA because of continuing serious deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm roasts and smokes canned sprat products which are imported to a U.S. establishment, and the firm’s HACCP plans were obtained during an inspection of “an importer of your canned sprat products.”

Staff from the FDA reviewed a response from the firm that “included a description of corrective actions, revised HACCP Plans dated April 16, 2018, for (its) roasted and smoked canned sprat products, completed monitoring records, as well as additional documents pertaining to product specifications and sampling.” However, according to a July 3 warning letter, the firm’s roasted sprats in tomato sauce, smoked sprats in oil, and smoked sprats in tomato sauce products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

“Your plans do not include any critical limit to address excessive histamine formation in each lot at the receipt. In addition to decomposition and internal temperature controls at receiving, FDA also recommends either obtaining harvest vessel records that document capture and holding conditions onboard the vessel; or establishing a histamine testing strategy using a critical limit of 50 ppm for histamine as a part of your receiving process,” according to the warning letter.

“You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point,” however, “your firm’s revised HACCP plans dated April 16, 2018, entitled ‘Roasted Sprats in Tomato sauce,’ ‘Smoked sprats in tomato sauce’ and ‘Smoked sprats in oil’ list monitoring procedures that are not adequate to control histamine formation.”

Additionally, the FDA noted that the firm should include documentation reflecting the changes they made, such as a copy of their revised HACCP plans, five consecutive days of completed monitoring records (i.e., records for the production of five production date codes of the products) to demonstrate implementation of the plan, and any additional information that they wish to supply that provides assurance of their intent to fully comply now and in the future with the applicable laws and regulations.

Ramirez & Ca. (Filhos), Porto, Portugal 
In a May 3 warning letter to Mr. Paulo Vaz Machado, staff from the FDA discussed the Dec. 7 through Dec. 8 inspection of the firm’s seafood processing facility; “That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.”

According to the warning letter, the firm responded to the FDA via email on December 27, 2017, stating that their HACCP plan is “under revision” and “will be completed end of first 2018 quarter.” Additionally, at the request of the FDA, the firm submitted a revised HACCP plan on February 23, 2018, entitled “HACCP Plans Sardines in different sauces.” The FDA evaluated that revised HACCP plan and found that the firm has continuing serious deviations of the seafood HACCP regulation.

“Your canned sardines packed in different sauces are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.”

FDA inspectors noted several significant violations.

The firm’s revised HACCP plan for canned sardines packed in difference sauces does not list the critical limits adequate to control the food safety hazard of scombrotoxin (histamine) formation.

“Your firm is a primary processor receiving the fish directly from the harvest vessels. Consequently, your firm needs to ensure control of scombrotoxin (histamine) formation that is reasonably likely to occur while the sardines are onboard the harvest vessel,” Furthermore, “all primary processors need to include sensory examination of a representative sample of scombrotoxin forming fish that shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample.”

Additionally, the firm is not located at the wharf where the sardines are off-loaded from the harvest vessel, and consequently the sardines are in transit prior to receipt; “FDA recommends for control of scombrotoxin (histamine) formation during transit to the facility from the wharf, that firms ensure the products were maintained under proper refrigerated temperatures or that the products were completely surrounded by ice for the duration of the transit period.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

Taiwan Sing Rong Food Co. Ltd., Kaohsiung City, Taiwan
Taiwan Sing Rong Food Co. in Kaohsiung City, Taiwan, is on notice from the FDA because of “continuing” serious deviations from the Seafood HACCP regulation, under the Act. Accordingly, the firm’s frozen Hot Pot (fish) dumpling product is adulterated, in that it has been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

According to the April 9 warning letter, the FDA discussed a Jan. 8 response letter from the firm that included revised pages of their HACCP plan, completed monitoring records, and photographs; “We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation.”

Upon inspection, the FDA observed the following significant deviations:

  • The pages of the firm’s HACCP plan for Hot Pot (fish) dumpling provided with their January 8, 2018 response lists critical limits that are not adequate to control their identified hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse;
  • The firm’s packaging plan for squid creates a potential for toxin formation (i.e., Clostridium botulinum growth and toxin formation) because the oxygen in the bags could be depleted during thawing, creating anaerobic conditions.
  • The FDA observed no frequency provided for when or how often monitoring procedures for each critical control point are checked are performed; “intermittent manual temperature checks are not adequate for steps that expose the product to potential time and temperature abuse and the FDA recommended that the firm have a continuous time/temperature recording device.”

The FDA noted the following additional comments:

  1. Please ensure that the packages of your frozen products, including your Hot Pot (fish), Shrimp Rolls, Cuttlefish Rolls and Egg Dumpling (i.e., with fish paste) have handling instructions to consumers to “Thaw Under Refrigeration; Use Immediately Before Use”, or similar instructional language to ensure that the products are properly thawed prior to consumption;
    2.  Please provide the entire HACCP plan for your Hot Pot (fish). Your January 8, 2018 response includes only 2 pages from the plan; and
    3.  Please provide the HACCP plans for your Shrimp Rolls, Cuttlefish Rolls and Egg Dumpling (i.e., with fish paste).

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