As part of its enforcement activities, FDA issues warning letters to entities under its jurisdiction. Some letters are not released for public viewing until weeks or months after they are mailed. Business owners have 15 days to respond to the FDA warning letter. Warning letters are usually issued after the company has been given months to years to correct the problem.
CR Grupo Comercial Alvacora SA
Nicaragua Managua
The United States notified a Nicaraguan food company that the FDA had violated the Seafood Hazard Analysis and Critical Control Points (HACCP) regulations for serious violations.
In the warning letter dated August 15, 2022, FDA describes the warning letter dated April 18-22, 2022, CR Grupo Comercial Alvacora SA in Managua, Nicaragua Foreign Remote Regulatory Assessment (FRRA) for Seafood Processing Facilities.
FDA’s inspection found serious violations, including failure as a processor of fish or fishery products to comply with the development and implementation of an FDA-compliant HACCP plan. Some major violations are as follows:
1. The company must have a HACCP plan that lists at least the key constraints 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 the occurrence of an identified food product to an acceptable level. Safe However, the company’s HACCP plan, revised in January 2022, listed key limitations for dried sea cucumbers in the drying CCP, at (REDACTED) Celsius ( edited) Fahrenheit (edited ) days and final weight of product is (redacted) percentage of initial weight, not enough to control pathogen growth and toxin formation in its shelf-stable products. FDA recommends that their critical limits also list a target water activity of 0.85 or less in finished products. The water activity of the finished product should be analyzed from the collected samples to be representative of each batch of product. Alternatively, their critical limits may list a target water activity of 0.85 or less, and the critical factors (eg, minimum percent weight loss, drying temperature, and time) required to achieve the target water activity determined by scientific research. With this control strategy, water activity testing should be listed as a verification procedure in their HACCP plan and should be analyzed at least every three months.
Also, they have a drying time of (redacted) degrees Celsius (REDACTED) (REDACTED) Days in Fahrenheit may be Allow pathogen growth to reach unsafe levels before reaching target water activity. Therefore, they should increase the drying temperature to at least 57.2 degrees Celsius (135 degrees Fahrenheit), or ensure a water activity of 0.85 or less within two hours of drying to control pathogen growth and toxin formation.
In addition, their drying CCP lists monitoring procedures for critical limits of final weight of the product (redacted) % of the initial weight is not enough. The monitoring program should list weight records at the beginning and end of drying.
2. Because companies choose to include a corrective action plan in their HACCP plan, the corrective actions they describe must be appropriate. However, they listed “(redacted)” corrective actions in the Dried Sea Cucumber HACCP Plan for the Drying CCP, which was insufficient to control pathogen growth and toxin formation. Corrective actions must prevent adulterated food from entering commercial circulation and correct the cause of deviation. The FDA recommends that their corrective actions list cooling and holding the product until a food safety assessment can be performed before continuing to dry, and list actions aimed at correcting the cause (for example, adjusting temperature or humidity or re-evaluating the drying process).
Misbranded
1. The company’s “Pepino Petate” product was mislabeled because the product label did not contain the generic name of the food. For example, product labels did not declare the identity of the food in English on the main display board as required. Additionally, the product was reportedly referred to as “sea cucumber” and “dried sea cucumber”; however, these descriptors were not used for its current name on the product’s label (which translates to “cucumber pete”).
2. The company’s “Pepino Petate” product was misbranded because it couldn’t accurately state the net content in pounds, with the remainder in ounces or the normal or fractional part of pounds, followed by a metric statement. Additionally, FDA states that “Net. W.” does not meet the abbreviation provided.
The full warning letter can be viewed here.
Chaur Fong Inc. dba 888 Food Company
South Elmont, CA
A California food company was notified by the FDA for a serious violation of seafood hazard analysis and critical control points (HACCP) regulations.
In warning letter dated July 29, 2022, FDA describes inspections conducted June 9-28, 2022 of Chaur Fong Inc.’s seafood processing located in Southern California Elmont’s factory.
FDA inspection uncovered serious violations, including failure to develop and implement an FDA-compliant HACCP plan as a processor of fish or fishery products. Some major violations are as follows:
1. The company must have a HACCP plan that lists at least the key constraints that must be met. A critical limit is defined as “the maximum or minimum value at which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce the occurrence of an identified food safety hazard to an acceptable level.” However, The company’s HACCP program for refrigerated seafood RTE products, including Ho King brand fried fish balls, does not control botulism in (REDACTED) Staged critical control points for bacteriotoxin formation.
Specifically, its critical limit does not list the maximum thickness of packaged fish products based on its validation studies.
2. Companies must conduct a hazard analysis to determine whether there are reasonably likely food safety hazards and develop a HACCP plan that lists at least critical control points. A critical control point is defined as “a point, step or procedure in a food processing process at which a control can be applied so that a food safety hazard can be prevented, eliminated or reduced to an acceptable level”. However, the company’s HACCP plan for frozen products, including their Giai Phat brand of Featherback fish balls, does not list critical control points for frozen storage and is labelled to control the food safety hazard of botulinum toxin formation.
The full warning letter can be viewed here.
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