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FDA sends warnings to seafood facilities citing violations of seafood regulations


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.


CR Grupo Comercial Alvacora S.A.
Managua, Nicaragua

A food firm in Nicaragua is on notice from the U.S. FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In an Aug. 15, 2022, warning letter the FDA described an April 18-22, 2022, Foreign Remote Regulatory Assessment (FRRA) of CR Grupo Comercial Alvacora S.A.’s seafood processing facility in Managua, Nicaragua.

The FDA’s inspection revealed serious violations, including failure as a processor of fish or fishery products to have and implement a HACCP plan that complies with FDA requirements. 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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s revised HACCP plan, dated January 2022, for dried sea cucumbers at the drying CCP lists critical limits, of drying at (redacted) degrees C (redacted) degrees F for (redacted) days and the final weight of the product to be (redacted) percent of the initial weight, that are not adequate to control pathogen growth and toxin formation in their shelf-stable product. FDA recommends that their critical limits also list a target water activity of 0.85 or less in the finished product. The water activity of the finished product should be analyzed from samples collected to be representative of each batch. Alternatively, their critical limits can list the target water activity of 0.85 or less and the critical factors (e.g., minimum percent weight loss, drying temperature and time) as established by a scientific study that are needed to achieve the target water activity. With this control strategy, the testing of the water activity should be listed as a verification procedure in their HACCP plan and the analysis should be conducted at least every three months.

Additionally, their drying at (redacted) degrees C (redacted) degrees F for (redacted) days could allow pathogen growth to reach unsafe levels before the target water activity is reached. Thus, they should either increase the drying temperature to a minimum of 57.2 degrees C (135 degrees F) or ensure a water activity of 0.85 or less is achieved within two hours of drying to control pathogen growth and toxin formation.

Furthermore, their drying CCP lists a monitoring procedure for the critical limit of final weight of the product to be (redacted)% of the initial weight that is not adequate. The monitoring procedure should list the recording of the weight at the beginning and at the end of drying.

2. Because the firm chose to include a corrective action plan in their HACCP plan, their described corrective actions must be appropriate. However, their HACCP plan for dried sea cucumbers at the drying CCP lists the corrective action of “(redacted)” that is not adequate to control pathogen growth and toxin formation. Corrective actions must prevent the distribution of adulterated food into commerce and correct the cause of the deviation. FDA recommends that their corrective actions list chilling and holding the product until a food safety evaluation can be performed prior to continued drying and list actions intended to correct the cause (e.g., adjustment of temperature or humidity or reevaluation of the drying process).

Misbranding

1. The firm’s “Pepino Petate” product is misbranded in that the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food in English on the principal display panel as required. Further, the product is reported to be called both “sea cucumber” and “dried sea cucumber;” however, these descriptors are not used in the name currently on their product label (translated to be “cucumber petate”).

2. The firm’s “Pepino Petate” product is misbranded because it fails to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Further, the FDA notes that the term “Net. W.” is not in accordance with the abbreviations provided.

The full warning letter can be viewed here.

Chaur Fong Inc. dba 888 Food Company
South El Monte, California

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 July 29, 2022, warning letter the FDA described a June 9-28, 2022, inspection of Chaur Fong Inc.’s seafood processing facility in South El Monte, CA.

The FDA’s inspection revealed serious violations, including failure as a processor of fish or fishery products to have and implement a HACCP plan that complies with FDA requirements. 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 Refrigerated Seafood RTE Products, including Ho King brand Fried Fish Balls, does not list a critical limit(s) at (redacted) Stage critical control point to control Clostridium botulinum toxin formation.

Specifically, their critical limit does not list maximum thickness of packaged fish products in accordance with their validated study.

2. The firm must 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. A critical control point is defined as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can, as a result, be prevented, eliminated, or reduced to acceptable levels.” However, the firm’s HACCP plan for Frozen Products, including their Giai Phat brand Featherback Fish Balls, does not list the critical control point of frozen storage with labeling for controlling the food safety hazard of Clostridium botulinum toxin formation.

The full warning letter can be viewed here.

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