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.
U-Can Food Trading Inc.
Los Angeles, 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 Jan. 23 warning letter, the FDA described a Nov. 30, 2022, inspection of U-Can Food Trading Inc.’s seafood importer establishment.
The FDA’s inspection revealed that the firm was not in compliance with federal regulations, specifically serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. These violations resulted in the issuance of an FDA Form 483. The significant violations are as follows:
The firm did not comply with FDA regulation in that they do not have or 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 did not have written verification procedures, product specifications, and affirmative steps for the Shrimp Paste imported from (redacted) under Entry HK1-2203184-0. The FDA acknowledged that in their Dec. 29, 2022, response, they provided written verification procedures, product specifications, and affirmative steps for the Shrimp Paste they imported from (redacted). However, their affirmative step is not adequate. The provided certificate did not specify any documentation or certification that the Shrimp Paste was processed in accordance with FDA’s requirements or FDA Seafood HACCP regulation. Furthermore, their provided analytical summary of a laboratory report, dated March 16, 2022, is not adequate to satisfy the affirmative step because it was not accompanied by a written guarantee from the foreign processor that the imported fish or fishery product is processed. Additionally, the certificate and laboratory report reference a different firm than the foreign processor transmitted as the manufacturer under the entry HK1-2203184-0 without any justification or explanation.
- The firm did not have written verification procedures, product specifications, and affirmative steps for the Salted Jelly Fish Whole, Salted Jelly Fish Shredded, and Salted Jelly Fish Head imported from (redacted) under Entry HK1-2203088-3. Their submitted response did not address these imported products.
The full warning letter can be viewed here.
RDM Express Inc.
San Francisco, 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, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), and sanitation issues, including rats.
In a Dec. 12, 2022 warning letter, the FDA described a Sept. 5-15, 2022 inspection of RDM Express Inc.’s ambient, refrigerated, and frozen warehouse facility in San Francisco, CA.
The FDA’s inspection revealed that the firm was not in compliance with federal regulations, specifically serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule). These violations resulted in the issuance of an FDA Form 483. The significant violations are as follows:
1. The firm must implement the monitoring procedures that they have listed in their HACCP plan. However, their firm did not implement the following monitoring procedures as listed in their HACCP plan for Herring Fillets in Oil.
a) They did not visually check the data generated by a temperature recording device during transit at their receiving critical control point (CCP) to control the listed hazards of C. botulinum toxin and histamine formation.
Specifically, on Aug. 29, 2022, they received the following Herring Fillets in Oil products:
Upon receipt of these reduced oxygen packaging (ROP), ready-to-eat (RTE) products, they did not review any transportation records as required by their HACCP plan. The firm explained to the investigator that their standard practice is (redacted) to obtain a temperature upon receipt and record the temperature on their receiving log. This procedure is not what their plan requires, it is not adequate to ensure that proper temperatures were maintained during transit, and it is a repeat violation from the FDA inspection that ended on Dec. 6, 2017.
b) The firm did not check a continuous temperature recording for their cooler (redacted) as required by their HACCP plan at their refrigerated storage CCP with a critical limit of “Cooler temperature of (redacted)” to control for the listed hazards of pathogenic bacteria growth and toxin formation, C. botulinum toxin formation, and histamine formation. Specifically, the firm’s cooler does not have a continuous temperature monitoring device. Additionally, they stated to the investigator that their standard practice is to (redacted). This procedure is not what the firm’s plan requires and is not adequate to ensure that a proper temperature is maintained in the cooler.
Regarding the inadequacy of their monitoring, on Sept. 7, 2022, FDA investigators used a calibrated traceable thermometer to take the following temperature readings from the cooler where they stored all their refrigerated seafood products, including ROP, RTE Herring Fillet in Oil:
- At 8:15 a.m., the cooler temperature readout was 46.9 degrees F
- At 1:30 p.m., the cooler temperature readout was 54.6 degrees F
- At 3:10 p.m., the cooler temperature readout was 58.4 degrees F
Furthermore, the firm did not have documentation showing that the thermometers they use have been calibrated for accuracy to comply with regulation for the calibration of process-monitoring instruments. These are repeat violations from the FDA inspection that ended on Dec. 6, 2017. The FDA noted that during the inspection the firm moved all their seafood products from the cooler to the freezer. Further, they stated that all seafood products will be stored in the freezer until they are able to install a continuous monitoring system for the cooler.
2. Because the firm chose to include a corrective action plan in their HACCP plan they described corrective actions must be appropriate to comply with regulation. However, their corrective action plan for their Herring Fillets in Oil listed hazards of pathogenic bacteria growth and toxin formation, C. botulinum toxin formation, and histamine formation at the Receiving and Refrigerated Storage CCPs is not appropriate. The firm’s corrective actions fail to ensure the cause of the deviation is corrected, such as discontinuing the use of the supplier until transit practices have improved and adjusting or repairing the cooler.
1. The firm must monitor the conditions and practices during processing with sufficient frequency to ensure conformance with the current good manufacturing practice requirements, that are both appropriate to their plant and the food being processed. However, the firm did not monitor for the presence of pests in the food plant with sufficient frequency to ensure that pests are not allowed in any area, as required. This is related to the exclusion of pests from the food plant. Specifically, on Sept. 7 and 8, 2022, FDA investigators observed the following in their ambient food storage area:
a) There were many large, rat apparent rodent excreta pellets (AREPs) found along the entire perimeter (approximately 15 locations with 10 – 50 AREPs at each location) of their approximately (redacted) ambient storage area in the back of their facility.
b) There were rat AREPs along approximately 25 percent of the perimeter wall in the approximately (redacted) middle area of the facility.
c) There was a pallet of canned fish in jars with a cardboard box with seven jars of the canned fish also containing two apparent dead rats, cardboard nesting material, approximately 5 rat AREPs, an approximately 3″ x 1″ piece of pastry, possibly gingerbread, and five approximately 1″ x 1″ pieces of heart-shaped chocolates.
d) There were approximately ten locations with holes chewed through cardboard and chewed cardboard on pallets containing food products such as buckwheat, rice, pasta, and jars of mushrooms.
e) There was a large mass of shredded plastic, possibly nesting material, with a very strong smell of urine surrounded by approximately fifty large, rat AREPs, found behind a pallet of boxes of buckwheat.
f) There was a pallet of jars of pickled tomatoes with a box containing an apparent dead rat, approximately 20 rat AREPs, and apparent nesting material.
g) An apparent rodent gnaw hole was found on a bag of cavatappi pasta with manufacture date of 10/14/21 inside a case on a pallet of pasta.
h) There was a strong smell of urine in the eastern side of the middle part of the facility.
i) In the front part of the facility there was a pallet containing 3 cases of Tula Gingerbread with Cranberry Filling with manufacturing date 04/16/22. One case of the gingerbread had five apparently chewed packages, each also containing chewed product.
The presence of pests in a food facility can result in illness to consumers through microbial contamination. Rodents are known sources of Salmonella and parasites that can cause foodborne illness. This is a repeat violation from the FDA inspection that ended on Nov. 19, 2014, when FDA investigators observed apparent rodent excreta pellets and an apparent rat running across pallets of food product in the firm’s ambient temperature warehouse.
Additionally, during the inspection, on Sept. 8, 2022, FDA investigators collected samples for filth analysis by FDA laboratories and found the following violative results that support the above listed observations of rodent activities in their food storage areas.
- Sample 1189839 consisting of apparent rodent excreta pellets and nesting material was examined and found to contain rat excreta pellets, rat hairs, double incisor chew marks, live mites, dead insects, and urea.
- Sample 1189840 consisting of an apparent gnawed bag of Cavatappi pasta was examined and found to have at least 6 double incisor marks.
- Sample 1189841 consisting of an apparent gnawed bag of Tula gingerbread filled with fruit and berry filling was examined and found to have rodent double incisor marks.
The full warning letter can be viewed here.
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