A seafood processor in New York, and a milk-powder manufacturing facility in Minnesota are both 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 August and October, 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.

Threeline Imports Inc., Brooklyn, NY
Threeline 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, under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their United States facility.

Staff from the Food and Drug Administration inspected the Brooklyn, NY, location of Threeline Imports Inc. from April 19 through April 24. They discovered the “serious violations” regarding the firm’s affected products, according to an Aug. 18 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,” the warning letter states. “… 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 Malvina Kerzhner.

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 smoked sprats in oil, smoked sprats in tomato sauce, along with roasted sprats in tomato sauce intended to be distributed at ambient temperature 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 warning letter.

FDA inspectors noted the following significant violations.

The firm failed to implement an affirmative step that ensures fish and fishery products it imports are processed in accordance with the Seafood HACCP Regulation.

The FDA noted that the firm did not perform an affirmative step for the following ready-to-eat fishery products which are packaged in glass or metal jars, and distributed at ambient temperatures:

• Smoked sprats in oil;
• Smoked sprats in tomato sauce; and
• Roasted sprats in tomato sauce.

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

“For instance, we may take further action to refuse admission of your imported fish or fishery products, including placing them on ‘detention without physical examination,’ seize your products and/or enjoin your firm from further violating the Act,” the FDA warned.

“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.”

Bluegrass Proteins Inc., Dawson, MN
Bluegrass Proteins Inc. is on notice from the FDA because of significant violations of the Current Good Manufacturing Practice (CGMP) regulation, as well as the presence of Salmonella in environmental swab samples at its facility that produces milk-based powder.

“During the inspection FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food-contact surfaces,” according to the Oct. 26 warning letter.

Based on the FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, they determined that the firm’s food products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Staff from the Food and Drug Administration inspected the Dawson, MN, location of Bluegrass Proteins from May 22 to June 12.

The FDA acknowledged a response from the firm, which included a description of the corrective actions they had taken. The FDA addressed the “adequacy” of the following corrective actions:

• Environmental swabs found Salmonella in two separate subsamples collected from processing areas where food is likely to be exposed. This includes Salmonella Tennessee, and Salmonella Johannesburg. The FDA noted that this was a repeat offense; the FDA’s laboratory analysis confirmed Salmonella senftenberg in a 2016 inspection, as well as seven positive environmental samples identified as Salmonella species in a 2014 inspection.

“FDA acknowledges your written response dated June 26, 2017, which states the two subsample locations that tested positive for Salmonella were cleaned and sanitized by your cleaning crew, and have been re-sampled with negative results. We are unable to verify the adequacy of your response because we have not received any documentation or evidence of the cleaning or testing, along with information on implementation of sanitary practices to ensure continued compliance.”

• FDA investigators observed several significant violations of the CGMP regulation for foods. The firm failed to prevent water leaks in their facility. At least five areas throughout the vacated aseptic production and packaging area had water lines or steam lines that were actively dripping, creating puddles and causing damage to the floors. Additionally, rain was actively dripping through an external air filter housing unit, which was adjacent to an unused ingredient elevator shaft near the second floor bagging bins.

“Your firm’s response also stated that all areas with water or condensation were wet cleaned with detergent and sanitized as recommended by your current chemical provider. We will verify the adequacy of your corrective actions during our next inspection.”

•  The firm failed to hold food which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.

“Blocks of White Cheddar Cheese, wrapped in plastic and placed in wood crates, were stored in this cooler. The cheese appeared to be molding causing at least one crate to split apart. A black substance, identified as ‘whey’ by management, was running down the sides of the crates and pooling on the floor.”

• The firm failed to take precautions and restrictions when using insecticides to protect against the contamination of food, food-contact surfaces, and food-packaging materials and failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The FDA noted that pallets of various dairy powders intended for animal food showed apparent beetle-like insects within the shrink wrap and on the exterior bags of product.

“Your firm’s response states that your Pest Control Officer was made aware of the situation and confirmed all pest control activities in the future will be recorded on the inspection report; however, no documentation was provided to confirm this correction.”

• The firm failed to provide safety type light bulbs, fixtures, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.

“Pieces of a broken light shield were observed on the floor between pallets in the finished product warehouse near the Sapac Bagging room. The light bulb above the pallets was exposed. Pieces of a broken light shield were observed on the floor of the second floor warehouse near pallets of Varied Dairy Powder intended for Animal Feed. The light bulb was exposed.

“… You should include with your response documentation of all corrective actions taken, any training logs, and any other information that would assist us in evaluating your corrections.”

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