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.
Baits and Sea Foods, S.A.
Nicaragua
A food firm in Nicaragua is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a June 30, 2023, warning letter, the FDA described a May 8 through 11, 2023, inspection of Baits and Sea Foods, S.A. in Managua, Nicaragua.
The inspections found that the firm’s fresh and frozen histamine forming seafood products, including but not limited to mahi-mahi, are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Some of the firm’s significant deviation is as follows:
1. The HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the food safety hazard of Clostridium botulinum growth and toxin formation, and undeclared allergens as required.
2. The HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list as required:
a. A critical control point (CCP) at the receiving of fresh whole gutted mahi mahi that is necessary to control the hazards of histamine formation during transit from the local ports to the processing plant.
b. A critical control point at the fish storage between layers of ice that is necessary to control the histamine formation hazard. The fresh whole, gutted mahi mahi fish can be stored up to 48 hours between layers of ice.
3. The firm’s HACCP plan lists a critical limit that does not ensure control of one or more hazards. Specifically, their HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets does not list the sensory examination critical limit to control the histamine formation hazard at the receiving critical control point as required.
4. The firm’s HACCP plan lists monitoring procedures that do not ensure compliance with the critical limit. Specifically, the HACCP plan for histamine forming species including frozen, raw, individually vacuum-packaged, wild caught, mahi-mahi portions and fillets as required:
a. Lists the incomplete monitoring procedure of “(redacted)”. This procedure does not ensure compliance with the critical limit at the receiving CCP. The monitoring procedure does not list the number of fish to be analyzed for histamine.
b. Lists incomplete monitoring procedures to monitor the internal temperature of the fish at the receiving CCP. The monitoring procedure does not list the minimum number of fish to be temperature checked.
5. The firm’s HACCP plan includes a corrective action plan that is not in accordance with regulation to ensure affected product is not entered into commerce and the cause of the deviation was corrected. Specifically, the HACCP plan for histamine forming species lists an inadequate corrective action procedure at the receiving CCP when the temperature measurement is above the critical limits.
The full warning letter can be viewed here.
New Manna Food
Guam
A food firm in Guam is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a June 12, 2023, warning letter, the FDA described a Feb. 1-3, 2023, inspection of New Manna Food in Guam.
In accordance with regulation, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operates in accordance with requirements, renders the fish and fishery products adulterated. A label review was also conducted of the Guam New Manna Foods tuna salad sandwich and found violations of Food Labeling, which causes the product to be misbranded. Additionally, the inspection found the firm failed to register as required. The failure to register a facility as required is a prohibited act.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility.
The firm’s significant deviation is as follows:
Seafood HACCP Violations
1. The firm does not have a written HACCP plan that outlines controls for any food safety hazards that are reasonably likely to occur, as required. Specifically, the firm does not have a HACCP plan for Guam New Manna Foods tuna salad sandwich to control the hazards of histamine, pathogen growth and toxin formation, and undeclared allergens. In addition, the firm has not conducted a hazard analysis for this product. The FDA investigator observed the following lack of controls during the inspection:
a) On Feb. 1 at 11:00 a.m., the temperature of their walk-in refrigerated storage was measured at 44 degrees F using the gauge on the wall of the walk-in storage. There were ingredients used in their tuna salad sandwich stored in this cooler at the time the temperature was observed, including tuna and mayonnaise. Finished product Guam New Manna Foods tuna salad sandwich were also observed being stored in this walk-in storage. The firm stated that the sandwiches would be distributed the next morning at about 4:30 a.m.
On Feb. 2 at 9:15 a.m., the temperature of the walk-in storage was measured at 48.7 degrees F using a probe thermometer (the accuracy of which was checked using ice water). At 9:35 a.m., the temperature was 46.2 degrees F and at 11:48 a.m., the temperature was 47.3 degrees F using the same probe thermometer. At all these times, mixed tuna salad was stored in the walk-in storage awaiting assembly into Guam New Manna Foods tuna salad sandwiches. They state that the finished product Guam New Manna Foods tuna salad sandwiches would be stored in the walk-in storage until distribution the next morning at about 4:30 a.m. They stated that they do not monitor or record the temperature of their walk-in storage. There is no continuous monitoring of the temperature, and no temperature alarm system on the walk-in storage.
b) Their Guam New Manna Foods tuna salad sandwiches are not labeled with a statement of identity, an ingredient statement, or allergen statement. The product contains the allergens of milk and soy from the bread, egg from mayonnaise, and fish (tuna).
2. They are not monitoring the sanitation conditions and practices with sufficient frequency to ensure compliance with Current Good Manufacturing Practice requirements including protection from adulteration (i.e., allergen cross contact) and exclusion of pests from the food plant, as required.
Specifically,
a) On Feb. 1, an FDA investigator observed at least four flies inside their processing room. The flies were observed landing on bread used for ready-to-eat Tuna Salad Sandwiches and on other ready-to-eat products and food contact surfaces.
b) On Feb. 1, an FDA investigator observed ham and cheese sandwiches were being manufactured, and then placing the in-process sandwiches directly on a stainless-steel table. After the ham and cheese sandwich manufacturing was completed, Guam New Manna Foods wiped off using a towel that was wet with plain water and proceeded to place tuna salad sandwiches on the same table. An FDA investigator also observed the same potential cross contact issues after the manufacture of the tuna salad sandwiches where egg salad sandwiches could be potentially adulterated with fish allergens from the work surface. When allergen cross contact presents a food safety hazard, processors must implement prevention controls that effectively remove or eliminate allergens from the work surface. Wiping down food contact surfaces with water does not appear to provide the necessary safety assurance that allergens have been eliminated from that surface. FDA recommends that cleaning operations include two steps, washing the surface with soap to remove particulates and then sanitizing the cleaned surface. The processor also has the option of scheduling the products being manufactured to eliminate the potential for allergen cross contact.
Failure to Register
The FDA has determined that their facility has failed to register their facility. The failure to register a facility as required is a prohibited. FDA records indicate that, to date of this warning letter, this facility has not been registered with FDA.
The full warning letter can be viewed here.
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