As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Amor Nino Foods, Inc.
Honolulu, HI
A food firm in Hawaii is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a June 26, 2023, warning letter, the FDA described a Jan. 11-24, 2023, inspection of Amor Nino Foods, Inc.’s seafood processing facility in Honolulu, HI.
The FDA’s inspection revealed that the firm was not in compliance with regulations which resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:
1. The firm must have a HACCP plan that, at a minimum, lists the critical limits that must be met. A critical limit is defined as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s HACCP plan for ready to eat, Hawaiian Style Skipjack Tuna Sticks (Hawaiian Style Aku Sticks) lists critical limits that are inadequate to control the hazards of Scombrotoxin formation and pathogen growth and toxin formation, specifically S. aureus toxin formation:
a. At the “(redacted)” critical control point, the listed critical limits “minimum drying time: (redacted)” and “Minimum product drying temperature (redacted)”.
b. At the “(redacted)” critical control point, the listed critical limits “Incorrect measurements of ingredients may increase the risk of either over dosing of (redacted) and/or increase the risk of pathogenic growth due to inadequate (redacted)”.
In addition, the firm has not conducted a validated study to demonstrate the critical limits under their current operating conditions will prevent the formation of histamine and the growth of pathogens during the drying process. Further, they stopped implementing the verification procedure of analytical testing (redacted) at these critical control points in July 2019.
The firm’s critical limits must be established by a scientific study to ensure that they are partially dried Aku strips reach a safe water activity within (redacted) is sufficient to prevent the hazards from (redacted). Further, 21 CFR 172.175 allows the use of the food additive sodium nitrate if it is used or intended for use as a color fixative in smoked cured tuna fish products so that the level of sodium nitrite does not exceed 10 parts per million (0.001 percent) in the finished product. (Redacted) is made in part of sodium nitrate; therefore, their critical limit of “(redacted)” may not exceed the established tolerance level for this food additive.
2. The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan and (redacted). However, the firm did not implement the monitoring procedures at the following critical control points listed in their HACCP plan for Hawaiian Style Skipjack Tuna Sticks (Hawaiian Style Aku Sticks) to control Scombrotoxin formation and pathogen growth and toxin formation, specifically S. aureus:
a. At “(redacted)” critical control point, the procedure is “Continuouse temperature monitoring device with alerts & alarms via sound, text messaging, & email.” They do not have a continuous temperature monitoring device at their (redacted) chill storage. FDA investigators observed they are monitoring temperature (redacted) per production day using a probe thermometer. This procedure is not what their plan requires and is not adequate to ensure that a proper temperature is maintained in the cooler.
b. At “(redacted)” critical control point lists a procedure of “Start time and end time of (redacted) temperature” for the critical limit of “Minimum (redacted) temperature: (redacted).” FDA investigators observed that the firm is not implementing this procedure. Further, they do not maintain records of monitoring.
The full warning letter can be viewed here.
Seafood Brothers Inc., DBA G&L Seafood Inc.
South El Monte, CA
A food firm in California is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a May 18, 2023, warning letter, the FDA described a March 23, 2023, inspection of Seafood Brothers Inc.’s seafood importer establishment in South El Monte, CA.
The FDA’s inspection revealed that the firm was not in compliance with regulations which resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:
1. The firm did not comply with regulation in that they do not have and have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish and fishery products they import are processed in compliance with the Seafood HACCP regulation.
Specifically, the firm does not have written verification procedures, product specifications, and or affirmative step for the Frozen Whole Clean Headless White Anchovy, and Frozen Whole Cooked White Clams both from the foreign processor (redacted), in (redacted).
For the Frozen Whole Tilapia, aquaculture from foreign processor, (redacted), in (redacted), their written verification procedure selected (redacted) for the affirmative step but they had the foreign processor’s HACCP plan for Tilapia, aquaculture. However, they did not have the written guarantee from (redacted), that the tilapia was processed in accordance with the Seafood HACCP regulations.
2. The firm did not comply with regulation in that they have not provided evidence that the fish they import have been processed under conditions that comply with the Seafood HACCP regulation.
Specifically, for the Frozen Whole Tilapia, aquaculture from foreign processor, (redacted), in (redacted), their product specification does not include parasite hazards, does not identify specific aquaculture drug hazards and specific tolerance and action levels for chemical hazards.
3. The firm did not comply with regulation in that their records do not include the date and time of the activity the record reflects and signature or initials of the person performing the operation.
Specifically, for the Frozen Whole Tilapia, aquaculture from foreign processor, (redacted), in (redacted), on June 29, 2022, their written verification procedure sections 1 and 2 were not completed and were not signed and dated.
The full warning letter can be viewed here.
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