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FDA sends warning letters to Indonesian seafood companies

Six seafood companies in Indonesia are 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 rules.

The FDA sent the warning letters to the companies in December of 2017 and January of 2018. 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.

Tritos Sejahtera, Jakarta, Indonesia
PTTritos Sejahtera in Jakarta, Indonesia, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their U.S. establishment.

Staff from the Food and Drug Administration inspected the Culver City, CA, location of Gourmet Fusion Foods Inc., a United States importer of the firm. They discovered “serious violations” regarding the firm’s “Frozen Tuna” HACCP plan, according to a Jan. 9 warning letter.

“As an importer of fish or fishery products, you must operate in accordance with the requirements … there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,”  according to the warning letter sent to company director, Richard Jeremya Simanjuntak.

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will be adulterated under the Act, and will be denied entry to the United States.

“Your firm’s HACCP plan entitled ‘Frozen Tuna’ does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. FDA recommends that your 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,” according to the warning letter.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.”

ShimassePrata Citra, Bekasi, Indonesia
In a Jan. 9 warning letter to PT Shimasse Prata Citra, staff from the FDA discussed the inspection of the firm’s Culver City, CA, importer, Gourmet Fusion Foods Inc.

“That importer was found to be importing fish and fishery products from your processing facility. During the inspection of the importer, we collected a copy of your HACCP plan entitled ‘Frozen Tuna’, dated March 24, 2016,” according to the warning letter.

“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.”

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will appear to be adulterated under the Act, and will be denied entry to the U.S..

FDA inspectors noted several significant violations.

The firm’s HACCP plan entitled “Frozen Tuna” does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation.

The FDA recommended 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.”

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

SuksesSejati, Jakarta, Indonesia
PT Sukses Sejati in Jakarta, Indonesia, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation, under the Act. The firm imports fish and fishery products to their United States facility.

According to the Jan. 9 warning letter, the FDA discovered and documented problems during an inspection at the company’s importing establishment in Culver City, CA, Gourmet Fusion Foods Inc. in relation to frozen, vacuum-packed tuna.

Upon inspection, the FDA observed the following significant deviations:

  • 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 critical limits are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant; and
  • The firm’s critical control point to control Clostridium botulinum toxin formation, your corrective action plan does not ensure that no adulterated product enters commerce.

Sekar Subur Abadi, Jakarta, Indonesia
PT Sekar Subur Abadi in Jakarta, Indonesia, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their U.S. establishment.

Staff from the Food and Drug Administration inspected the Culver City, CA, location of Gourmet Fusion Foods Inc., a United States importer of the firm. They discovered “serious violations” regarding the firm’s “Frozen Tuna” HACCP plan, according to a Jan. 9 warning letter.

“Your firm’s HACCP plan entitled ‘Frozen Tuna’ does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation,” according to the warning letter.

“FDA recommends that your 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,” according to the warning letter.

Anugerah Lestari Abadi, Bekasi, Indonesia
PT Anugerah Lestari Abadi, in Bekasi, Indonesia, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation, under the Act. The firm imports fish and fishery products to their United States facility.

According to the Jan. 9 warning letter, the FDA discovered and documented problems during an inspection at the company’s importing establishment in Culver City, CA, Gourmet Fusion Foods Inc.

The FDA inspectors observed the following significant deviations:

  • 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 critical limits are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant; and
  • The firm’s critical control point to control Clostridium botulinum toxin formation, your corrective action plan does not ensure that no adulterated product enters commerce.

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

 

Nusantara Jaya Abadi, Jakarta, Indonesia
PT Nusantara Jaya Abadi in Jakarta, Indonesia, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their U.S. establishment.

Staff from the Food and Drug Administration inspected the Culver City, CA, location of Gourmet Fusion Foods Inc., a United States importer of the firm. They discovered “serious violations” regarding the firm’s “Frozen Tuna” HACCP plan, according to a Dec. 29 warning letter.

“Your firm’s HACCP plan entitled “Frozen Tuna” does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. FDA recommends that your 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,” according to the warning letter.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.”

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