A Nebraska dairy, an airline catering facility, and a New York seafood and juice importer are all on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent the warning letters to the companies in May, November and December, and posted them for public view in recent days. 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.

Hilgenkamp Farm Inc., Arlington, NB
In a Nov. 15 warning letter to owners Milton and Ronald Hilgenkamp, the FDA described violations observed during an inspection Sept. 12 through 14 at the Hilgenkamp Farm Inc. operation in Arlington, NB. Investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the human food supply.

The FDA’s inspectors discovered drug residues in a dairy cow the company sold for slaughter as human food.

On or about May 24, the animal was slaughtered, according to the warning letter. During routine testing of tissue samples from the animal the USDA’s Food Safety and Inspection Service (FSIS)  found the antibiotic ceftiofur in the kidney at 6.691 parts per million (ppm), and the presence of flunixin at 0.213 ppm in the liver tissue.

The legal limit under federal law is 0.4 ppm for residues of ceftiofur in the edible tissues of cattle, and 0.125 ppm for residues of flunixin in edible tissues.

The dairy owner also failed to maintain adequate treatment records, according to FDA inspectors. Records on hand did not include the drug administered, dosage given, and route of administration. The firm also failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate animals, and failed to segregate treated animals. Specifically, “you keep treated animals together in the same pen with non-treated animals,” in which a treated animal could be offered for sale before proper meat withdrawals are met.

“We also found that you adulterated the new animal drug CeftiFlex® (ANADA 200-420, ceftiofur sodium sterile powder). Specifically, our investigation revealed that you did not use CeftiFlex® as directed by its approved labeling. Use of this drug in this manner is an extralabel use.”

The firm’s extralabel use of CeftiFlex® was not under the supervision of a licensed veterinarian and also resulted in illegal drug residues, according to the warning letter.

The dairy owner responded to the FDA’s warning letter, but it was “not adequate,” for example:

The firm indicated that only one person, the herdsman, will have access to the drugs and will be allowed to treat animals. “In a dairy operation, such as yours, it appears unrealistic to expect one person to be on duty 365 days a year.” The firm did not address how or who will be responsible for drug treatments when he is not on duty.

The firm not include any physical separation of animals being treated. During the inspection, the firm explained they physically separate animals into a hospital pen and mark them with a colored leg band when animals are under a drug withdrawal period for milk residues. But animals that are under a withdrawal time for meat residues are placed back with the rest of the cows with no such physical separation or markings.

“You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur,” the FDA advised.

As a producer of animals offered for use as food, firms are responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.

Tufos To Go LLC, Hebron, OH

In a May 19 warning letter to company owner Steven H. Tufo the FDA described violations observed during an inspection between May 25 and June 8 at the firm’s airline catering facility in Hebron, OH. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.

The violations cause products produced in the firm’s facility to be adulterated  “…in that they have been prepared, packed, or held under insanitary conditions wherby they may have become contaminated with filth, or wherby they may have been rendered injurious to heath.”

The following significant violations are noted regarding the adulterated foods:

All food-contact surfaces, including utensils and food-contact surfaces of equipment, are not cleaned as frequently as necessary to protect against contamination of food;

Buildings, fixtures, and other physical facilities of the plant are not being maintained in a sanitary condition or kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act;

Cleaning and sanitizing of utensils and equipment is not being conducted in a manner that protects against contamination of food, food-contact surfaces, or food packaging;

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food are not being conducted in accordance with adequate sanitation principles;

Appropriate quality control operations were not employed to ensure that food is suitable for human consumption, and overall sanitation of the plant is not under the supervision of one or more competent individuals assigned responsibility for this function;

Sanitizing agents are not adequate and safe under conditions of use;

Cleaned and sanitized portable equipment with food-contact surfaces and utensils were not stored in a location and manner that protects food-contact surfaces from contamination;

Toxic cleaning compounds, sanitizing agents, and pesticide chemicals were not identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials;

Employees were not observed washing their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated;

Effective measures are not being taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests;

All plant equipment and utensils are not so designed and of such material and workmanship as to be adequately cleanable, and properly maintained;

Single-service articles are not being stored in appropriate containers or handled in a manner that protects against contamination of food or food-contact surfaces; and

The firm failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.

According to the warning letter, the FDA acknowledged receipt of a written response from the firm. However, after reviewing the information, the FDA determined that the response is inadequate because it does not include sufficient detail or supporting documentation for the corrective actions. The FDA added that “These reported corrections will be evaluated during a subsequent inspection of your firm.”

Additionally, FDA records indicate that, to date, the firm’s facility has not been registered with FDA; “The owner, operator, or agent in charge of your facility, or an individual authorized by your facility’s owner, operator, or agent in charge, should register the facility with FDA immediately.”

Bedessee imports Inc., Brooklyn, NY
Bedessee imports Inc. in Brooklyn, NY, is on notice from the FDA because of significant deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, the juice Hazard Analysis and Critical Control Point regulation, and the Current Good Manufacturing Practice regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products, and juice, to their U.S. facility.

Staff from the Food and Drug Administration inspected the Brooklyn, NY, location of Bedessee imports Inc. from May 2 through May 16. They discovered the “serious violations” regarding the firm’s affected products, according to a Dec. 1 warning letter made public by the FDA in recent days.

“As an importer of fish or fishery products, you must operate in accordance with the requirements, … there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president Verman Bedessee.

If upon inspection, the FDA does not find assurance that the imported fish or fishery product have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will appear to be adulterated under the Act, and will be denied entry.

“Your Ready-to-eat Sardines in Tomato Sauce and Tomato Sauce with Chili and Ready-to-eat Mackerel in Water, Tomato Sauce, Hot Tomato Sauce and Soya Oil are adulterated in that they have been prepared, packed, or held under insanitary conditions wherby they may have been rendered injurious to health,” according to the warning letter.

The FDA also found serious deviations from the juice processing regulation. As “an importer of juice”, the firm’s “Fruit of Life Coconut Water (No Pulp)(Diabetic Choice)(17.5 oz/ 520 ml)” was found, “adulterated in that it has been prepared, packed, or held under insanitary conditions wherby it may have been rendered injurious to health.”

Additionally, the claims on the firm’s website “establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease,” resulting in the firm’s Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen to be misbranded.

“Your productsFruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen are intended for the treatment and prevention of one or more diseases that are not amenable to self-diagnosis or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded.”

Additionally, the FDA investigator observed the following significant violations of the Current Good Manufacturing Practice regulation for foods:

The firm failed to provide, wher necessary, adequate screening or other appropriate protection against pests; “Specifically, the FDA investigator observed 13 plastic strips in the loading dock that barred birds from entering the facility were cut and/or torn and three pigeons were observed roosting in the loading bay while the overhead door was open.”

The firm failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food; “Specifically, the FDA investigator observed pallets were stored directly against walls and in aisles hampering cleaning and inspection.”

The firm failed to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests; “Specifically, your firm was storing numerous empty boxes just inside the overhead door in the loading dock, just beyond an overhead door left ajar. Empty boxes and other debris may contribute to pests and pest harborage sites within food storage areas of your facility.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

“You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.”