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FDA warns foreign, domestic food producers of violations

The Food and Drug Administration recently made public warning letters sent to several companies in the U.S. and other countries about violations of federal food safety rules.

Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Yoder Farm Organics
A shell egg production facility in Bloomfield, IA, is on notice for serious violations of food safety regulations regarding the prevention of Salmonella Enteritidis during production, storage and transportation.

Officials from the FDA inspected the Bloomfield, IA, location of Yoder Farms Organics on Aug. 8, 2017, and discovered the company’s shell eggs were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, and may have been rendered injurious to health, according to a Jan. 26, warning letter recently made public by the FDA.

The report cited five significant violations in relation to Salmonella enteritidis (SE) prevention:

  • Failure to conduct environmental testing for SE, using the sampling and testing methodologies in the poultry house when the laying hens were 40 to 45 weeks of age; “Specifically, you indicated you performed testing on July 26, 2017, to ‘make up’ for the missing environmental test at 40-45 weeks of age and you could not provide documentation showing an environmental test was done at 40 to 45 weeks;”
  • Failure to properly implement your written SE prevention plan and failure to take the required number of samples for environmental testing using a sampling plan appropriate to the poultry house layout;
  • Failure to procure pullets that were SE monitored or raise pullets under SE monitored conditions; Specifically, documentation provided by the pullet grower shows that the pullet environment was tested when the pullets were 13 weeks of age (the pullet environment should be tested when pullets are between 14 and 16 weeks of age);
  • Failure to conduct environmental testing for SE in the poultry flock 4 to 6 weeks after the end of the molting process, and failure to provide documentation of when the firm’s flocks molt ends; “investigators noted that you describe the end of molt as the time when you stopped feeding the laying hens the molting ration. You tested the laying house environment on July 26, 2017, which is more than 4 to 6 weeks after the date you define as the end of molt;” and
  • Failure to properly implement their SE prevention plan; “you failed to properly implement the rodent and pest control measures outlined in Section Four: Rodent and Pest Control of your SE prevention plan, which calls for weekly monitoring of the rodent traps.”

Great American Marketing Co.
Great American Marketing Co. in Texas is on notice from the FDA because Listeria monocytogenes has been confirmed in the firm’s ready-to-eat (RTE) manufacturing facility.

“Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your RTE (ready-to-eat) food products such as Ham & Cheddar Sandwich, Turkey & Swiss Sandwich, Chicken Salad Sandwich, Deli Cut Ham & American Sandwich, and Jalapeño Pimento Cheese Deli Cut Sandwich are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act),” according to a warning letter the Food and Drug Administration sent to the company on Feb. 16.

The violations render the firm’s food products adulterated in that they have been prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.

Listeria monocytogenes causes serious, sometimes fatal, infections when people ingest it. Young children, the elderly and people with compromised immune systems are particularly at risk.

Staff from the FDA inspected the Houston location of Great Marketing Co. from July 24 through Aug. 4, 2017. Environmental samples collected from facility returned positive results during laboratory testing for Listeria monocytogenes.

“The presence of L. monocytogenes in your facility is significant in that they demonstrate your cleaning and sanitation practices are inadequate to effectively control pathogens in your facility to prevent contamination of food,” according to the warning letter.

“Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.”

Although the firm responded to the FDA in August with several letters including a narrative description of the corrective actions taken, the FDA noted unresolved, significant violations in the warning letter.

The FDA noted pathogen findings on an attachment of conveyor belt near a table, a seam between a table and conveyor belt, and the top of the conveyor belt; “Production employees assembling sandwiches placed RTE bread on the conveyor belt and sandwich ingredients were layered until assembled RTE sandwiches were cut and packaged for distribution.”

At this time, the FDA said they cannot verify the adequacy of the methods and controls described in the firm’s Aug. 24, 2017, response to identify the potential harborage sites for L. monocytogenes in their processing environment or effectively prevent it from contaminating finished products they may manufacture in the future. The FDA said they will evaluate the firm’s corrective actions during a future inspection.

Additionally, the FDA investigators observed the following significant violations:

  • In violation of the cGMP regulations for human food, investigators observed condensation dripping from a beam in the ceiling onto the floor of the production room where the firm manufactures ready-to-eat sandwiches;
  • The firm failed to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination; and
  • The firm’s Ham & Cheddar product declares major food allergens in both the ingredient statement and the “Contains” allergen statement, however, the FDA notes that the major food allergen “egg” has been declared within the ingredient list but not within the “Contains” statement.

If a “contains” statement is used, it must list all major food allergens present in the product.

Cermaq Chile S.A.
In an Aug. 25, 2017, warning letter to plant manager Adolfo Mohr Buhler, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and determined that the firm’s frozen vacuum-packaged aquacultured salmon are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

After the FDA inspectors visited the seafood processing facility in Chile on June 5 and 6, 2017, they noted that the firm should have 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. The company should also have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur.

A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, the firm’s HACCP plan for frozen vacuum-packaged aquacultured salmon does not list the food safety hazard of Clostridium botulinum toxin formation.

In addition to ensuring each vacuum-package is labeled with the statement “Keep Frozen, Thaw under Refrigeration immediately before use,” FDA recommends implementing controls for Clostridium botulinum toxin formation during the refrigerated storage of in-process vacuum-packaged salmon.

“During the inspection, our investigator was informed that your vacuum-packaged salmon can remain in the refrigerator for up to 48 hours,” according to the warning letter.

Ricker Hill Farms
Ricker Hill Farms in Turner, ME, is on notice from the FDA because of significant deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act).

“Accordingly, your apple cider is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”

The firm processes apple cider, and staff from the FDA discovered the “serious violations” regarding the firm’s affected products, according to the Feb. 15 warning letter.

According to the warning letter, the FDA collected a sample of the firm’s “Ricker Hill Orchards Apple Cider” manufactured at their facility on Aug, 31, 2017 and the FDA’s analysis revealed patulin level at 125 parts per billion (pub), more than twice the allowable level.

“Patulin is a toxic substance produced by molds that may grow on apples. FDA established an action level for patulin in apple juice of 50 ppb as determined on single strength apple juice or reconstituted single strength apple juice,” according to the warning letter.

The FDA acknowledged the firm’s recall of their Ricker Hill Orchards Apple Cider (half-gallon plastic jugs, UPC 7461380009) and Northland Apples Sweet Maine Cider (12-ounce plastic bottles, UPC 7461360009), but found the following significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation during their inspection:

  • The firm’s HACCP plan  critical limit is not adequate to control the patulin hazard; “FDA recommends that you perform a root cause analysis to determine the source of high patulin levels in your apple juice, implement additional critical control points if necessary, and establish appropriate critical limit(s) in your HACCP plan;”
  • The firm failed to maintain records documenting the monitoring of critical control points and their critical limits;
  • The firm’s corrective actions for their “Ricker Hill Orchards Apple Cider HACCP plan” does not address correcting the cause of the deviation, and their “Ricker Hill Orchards Apple Cider HACCP plan” corrective action fails to ensure adulterated product does not enter commerce; “FDA recommends segregating and holding product for reprocessing.”
  •  The firm failed to monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations;
  • “The cement floor under the filler in the jugging area is pitted and has areas of exposed rocks making it difficult to adequately clean and sanitize. We acknowledge that you plan to address the floor in the jugging area within the next two years. Insanitary conditions in this area are more likely to cause contamination of your finished product.”
  • “The right-hand side of the door frame leading from the cider press area into the apple storage cooler is damaged and missing pieces of wood. You indicated that the door frame would be repaired after the new equipment is installed. We will verify this during our next inspection.”
  • “Plastic strip type curtains at the entrance to the apple storage cooler and the entrance to the apple cider room are discolored, ripped and missing pieces. You indicate that the strip type curtains would be replaced within 1 month. We will evaluate the curtains during the next inspection.”
  • Labeling vilations were noted for the firm’s Apple Cider, Cran-Breeze, McIntosh Blend Carbonated Sweet Cider, Cran-Breeze Lightly carbonated, Maniac Gold, and Mainiac Mac products because they bear or contain a food additive which is unsafe; and
  • The firm’s Apple Cider, Cran-Breeze, McIntosh Blend Carbonated Sweet Cider, Cran-Breeze Lightly carbonated, Maniac Gold, and Mainiac Mac products are misbranded because they are fabricated from two or more ingredients and each ingredient is not declared on the label.

Haldiram Snacks Pvt. Ltd.
In a July 6, 2017, warning letter to managing director Pankaj Agarwal, the FDA described violations observed during an inspection April 18-19, 2017, at the firm’s low-acid food facility in Noida, India. According to the warning letter, the firm manufactures low-acid food products and low water activity controlled products. Serious violations of regulations for Emergency Permit Control, under the Current Good Manufacturing Practice (CGMP) regulation for foods, were observed.

“Accordingly, your LACF products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the letter.

All manufacturers of low-acid canned foods are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations related to the processing of LACF and current good manufacturing practices.

Significant violations of Emergency Permit Control & LACF and CGMP observations were as follows:

  • A critical factor specified in the scheduled process the firm filed for processing their low-acid food in hermetically sealed containers was not measured and recorded at intervals of sufficient frequency to ensure that the critical factor was within the limits specified in the filed scheduled process;
  • “…you did not monitor the viscosity for your Dal Makhni product packed in pouches that were manufactured on February 2, 2017.”
  • The firm failed to firm failed to process each low-acid canned food in conformity with at least the scheduled process; and
  • The firm failed to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control.

In addition to the above deviations, the FDA added, “please be aware that the calibration of the thermometer used to monitor your pasteurization should be repeated as necessary. We acknowledge your response included records demonstrating your firm’s calibration of the thermometer used to monitor the temperature of the pasteurizer; however, we note that calibration should occur as frequent as necessary to adequately maintain the equipment in accordance with current Good Manufacturing Practices.”

Magadoo Corporation Co. Ltd.
In an Oct. 6, 2017, warning letter to company vice president Jaren Srichanil, the FDA described violations observed during an inspection Aug. 21-22, 2017, at the company’s facility where they manufacture acidified food products. The Thanyaburi, Thailand, commercial manufacturing facility engages in the thermal processing of acidified foods, according to the warning letter.

Acidified food processors are required by federal law to comply with Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food, which includes taking effective measures to keep conditions sanitary.

According to the warning letter, the FDA acknowledged receipt of the firm’s response received via email dated Sept. 4, 2017, which included documentation describing production processes and details of their food products; “However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.”

The firm failed to file scheduled processes with the FDA for their products, including but not limited to Indian Trumpet Fruit Pickle and Fig Pickle, which have been determined to be acidified food products.

“As a commercial processor of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size.”

The inspector also noted that, “In addition, a commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of acidified foods to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA.” However, their FDA’s inspection indicates that the firm processes acidified food products without being registered as a processor of acidified foods.

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