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.
Vlazar Costa Caribe S.A.
Puerto Cabezas, Nicaragua
An exporting 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 26-29, 2022, Foreign Remote Regulatory Assessment (FRRA) of Vlazar Costa Caribe S.A.’s seafood processing facility in Puerto Cabezas, 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:
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 (Version 2) for Precooked Dried Sea Cucumber does not list the critical control point of drying for controlling the food safety hazard of pathogenic bacteria growth and toxin formation (Staphylococcus aureus).
The full warning letter can be viewed here.
Mahi Frozen Foods
Karachi, Pakistan
An exporting food firm in Pakistan 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 4-8, 2022, Foreign Remote Regulatory Assessment (FRRA) of Mahi Frozen Foods’ seafood processing facility in Karachi, Pakistan.
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 conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce 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 food safety hazards that are reasonably likely to occur. Specifically, their firm processes several species of fish (unicorn fish, grouper, red snapper, and amberjack) which have been associated with CFP.
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. However, their firm’s HACCP plan for “Fish Fillets” does not list critical control points for the following processing steps:
a. At the “(redacted)” step to control the food safety hazard of scombrotoxin (histamine) formation. The firm receives mahi-mahi and amberjack from local fishermen. They then transport the fish approximately one hour from the vessels and docks to their processing facility. Their hazard analysis incorrectly identified the “(redacted)” step as an Operational Prerequisite Program (OPRP) and did not consider the receiving of the fish at offloading and after transportation of the fish from the offloading location to the processing facility.
The FDA noted that their operational prerequisite programs (OPRP) plan list critical limits for some of these controls that may not provide an equivalent assurance of safety. Specifically:
i. Their OPRP plan’s critical limit of “(redacted)” is not adequate to control scombrotoxin formation. This critical limit is for fish held iced or refrigerated (not frozen) onboard the harvest vessel from 12 to less than 15 hours after death. The firm receives fish from harvest vessels that could potentially hold the iced fish up to one week before returning to port. For fish held iced or refrigerated (not frozen) onboard the harvest vessel 24 or more hours after death, the internal temperature should be 40 degrees F (4.4 degrees C) or below at receipt. In addition, their plan’s monitoring procedures should ensure that internal temperatures are recorded during off-loading.
ii. The firm’s OPRP plan’s critical limit of “(redacted)” states, “(redacted).” Since lots vary in size, FDA recommends that sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible odors) in less than 2.5 percent of the fish in the sample.
Additionally, the firm transports the fish they buy from the harvest vessels or docks to their processing facility. Their OPRP plan does not include a critical limit for internal temperatures to ensure the fish were held at or below an ambient or internal temperature of 40 degrees F (4.4 degrees C) throughout transit and that time of transit does not exceed 4 hours.
b. At the “(redacted)” step to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, their hazard analysis incorrectly identified this step as a prerequisite program. FDA regulations do not allow replacement of critical control points with prerequisite programs as an alternative to listing controls in a seafood HACCP plan. Their firm processes mahi-mahi and amberjack, both of which are histamine-forming fish. The firm’s Process Description describes, “(redacted)” and, “(redacted).” FDA investigators were told that the soaking process could take up to 24 hours. The “(redacted)” step should be identified as a critical control point in their revised HACCP plan to prevent histamine formation.
The firm has the option of maintaining ambient temperatures below 40 degrees F (4.4 degrees C) during the “(redacted)” step or controlling cumulative exposure times to ensure fish are not exposed to ambient temperatures above 40 degrees F (4.4 degrees C) as described above. When establishing critical limits at this processing step, they should consider all cumulative exposure times that can occur in multiple processing steps where fish are exposed to ambient temperatures above 40 degrees F (4.4 degrees C). This may require additional critical control points to control overall cumulative exposure times. According to their firm’s Process Description, there is potential for scombrotoxin-forming fish to be exposed to ambient temperatures above (redacted) degrees F (redacted) degrees C) during the “(redacted),” “(redacted),” “(redacted),” “(redacted),” and “(redacted)” steps and their HACCP plan does not address cumulative time and temperature exposures.
The full warning letter can be viewed here.
Myllan-ORA ehf
Kópavogur, Iceland
An exporting food firm in Iceland 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. 30, 2022, warning letter the FDA described a May 24 and 25, 2022, inspection of Myllan-ORA ehf’s seafood processing facility in Kópavogur, Iceland.
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. The firm’s ready-to-eat (RTE) herring and RTE refrigerated lumpfish caviar products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. The inspection resulted in the FDA’s issuance of an FDA-483.
Some of the significant violations are as follows:
1. The firm’s HACCP plan does not list one or more critical control points (CCPs) that are necessary for each of the identified food safety hazards as required. Specifically, their HACCP Plan for Bemka brand RTE refrigerated lumpfish caviar in glass jars, does not identify the following CCPs:
a. Receiving of refrigerated salted caviar in barrels, to control the hazard of toxin formation by Clostridium botulinum and Staphylococcus aureus. Their HACCP plan should list a CCP for the receiving with a critical limit that ensures these barrels of caviar were maintained at 40 degrees F (4.4 degrees C) or less throughout transit. This CCP is needed because the barrels are received refrigerated and they check the brine concentration and add brine if the salt content is lower than 18% indicating that this product may not consistently be shelf-stable, and refrigeration could be needed for food safety. Although their firm subsequently pasteurizes this product, their HACCP plan still needs to control for the formation of heat-stable toxins that will not be eliminated by their (redacted) step that is listed to control Listeria monocytogenes.
Additionally, the firm is evaluating the salt concentration of the product which is not adequate. They should evaluate the water phase salt (WPS) content of the product which is calculated by multiplying the percent salt by 100 and dividing by the sum of the percent salt plus the percent moisture. As an alternative to WPS, they can measure the water activity of the product. Water activity and WPS are correlated, and these analyses provide a better measurement of the available moisture in the product for pathogen growth and toxin formation than percent salt by itself. A seafood product should consistently have a verified minimum WPS of 20 percent or a maximum water activity of 0.85 to be considered shelf-stable and not need this CCP for refrigerated receiving.
b. Refrigerated storage of the salted caviar in barrels after receiving to control the hazard of toxin formation by C. botulinum and S. aureus. Their HACCP plan should list a CCP for their refrigerated (redacted) step of the barrels of caviar with a critical limit of 40 degrees F (4.4 degrees C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily. This CCP is needed because they were not able to provide documentation to demonstrate that the product they receive is shelf-stable, meaning it was processed in a manner that does not require refrigeration for food safety. Alternatively, this CCP would not be needed if they had a receiving CCP for adjusting the brine to a minimum WPS of 20 percent or a maximum water activity of 0.85.
c. Addition of water and other ingredients to the salted caviar to lower the salt content to 6.5% before filling in hermetically sealed glass jars to control the hazard of nonproteolytic C. botulinum growth and toxin formation in their finished product. Their HACCP plan should list a CCP for this (redacted) step with a critical limit that ensures the refrigerated finished product has a minimum WPS of 5 percent or a water activity below 0.97 with monitoring of each batch by collecting samples to be representative of the entire batch. Although, these jars are subsequently pasteurized their HACCP plan indicates that the target pathogen is L. monocytogenes which does not provide sufficient thermal destruction to control C. botulinum growth and toxin formation.
d. Finished product storage to control the hazard of proteolytic C. botulinum growth and toxin formation. The firm’s HACCP plan should list a CCP for their refrigerated (redacted) step of the glass jars of caviar with a critical limit of 40 degrees F (4.4 degrees C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily.
2. The firm’s HACCP plan does not list one or more critical control points (CCPs) that are necessary for each of the identified food safety hazards as required. Specifically, their HACCP Plan for Matjes brand RTE refrigerated spiced canned herring in marinade, does not identify the following CCPs:
a. Receiving of marinated, spiced herring fillets in barrels, to control the hazards of histamine formation and pathogen growth and toxin formation including C. botulinum during transit. Their HACCP plan should list a CCP for the receiving with a critical limit that ensures these barrels of RTE herring were maintained at 40 degrees F (4.4 degrees C) or less throughout transit. This CCP is needed because they were not able to provide documentation to demonstrate that the product they receive is shelf-stable.
b. Refrigerated storage of marinated, spiced herring fillets in barrels after receiving, to control the hazards of histamine formation and pathogen growth and toxin formation including C. botulinum. Their HACCP plan should list a CCP for their refrigerated (redacted) step of the barrels of RTE herring with a critical limit of 40 degrees F (4.4degrees C) for the ambient temperature of the cooler and continuous temperature monitoring with a visual check of the recorded data at least daily. This CCP is needed because they were not able to provide documentation to demonstrate that the product they receive is shelf-stable.
3. The firm must implement the monitoring procedures that they have listed in their HACCP plan. However, the firm did not follow the monitoring procedure of measuring the pH of the product to ensure the pH is ≤4.4 at the pH measurement CCP to control C. botulinum growth and toxin formation in their finished product of RTE refrigerated spiced canned herring in marinade. Their quality assurance employee was observed to take the pH of the marinade and not the product as listed in their HACCP plan. When instructed to take the measurement of a slurry of the fish product and marinade, the pH was found to be higher than that of the marinade alone.
4. The firm’s HACCP plan lists a monitoring frequency that does not ensure compliance with the critical limit as required. Specifically, their HACCP Plan for Matjes brand ready-to-eat (RTE) refrigerated spiced canned herring in marinade lists a monitoring frequency of taking the pH of the product from one sample per batch which is not adequate to control C. botulinum growth and toxin formation in the finished product. Their monitoring procedure should ensure the collection of a specified number of finished product samples based on the size of the batch to be representative of the entire batch.
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 as required. Specifically, their HACCP Plan for Matjes brand RTE spiced herring in marinade solution packed in cans, includes a corrective action plan at the pH measurement and labeling CCPs that are not in accordance regulation to ensure that the cause of the deviation was corrected.
a. At the pH Measurement CCP, their corrective actions state that “(redacted).” However, there is no corrective action listed for the process to ensure the cause of the deviation is corrected, such as modifying the pH adjustment procedure.
b. At the Labeling CCP, their corrective actions states “(redacted).” However, there is no corrective action listed for the process to ensure the cause of the deviation is corrected, such as modifying the labeling procedure or working with label supplier.
6. They are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces as required. Specifically, the sanitizer used for food-contact surfaces, didecyldimethylammonium chloride, which is a form of quaternary ammonium chloride, is not adequate for use. The chemical is supplied as a solution with a concentration of (redacted) parts per million (ppm). The firm uses a (redacted) solution of this chemical (approximately (redacted) ppm), applied after cleaning with soap, and then rinsed after (redacted) minutes. Quaternary ammonium compounds are not supposed to be rinsed after these have been applied to the food-contact surfaces so as not to lose its efficacy and regulation states that the effective usage level for this type of quaternary ammonium compound is 150 to 200 ppm.
The full warning letter can be viewed here.
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