Listeria monocytogenes growing on equipment and other surfaces in a Tacoma, WA, fish processing plant and filthy conditions with evidence of insect infestations in a St. Paul, MN, bakery earned business owners warning letters from the Food and Drug Administration recently.

In the most recent batch of warning letters made public by the FDA, federal officials gave the owners of the fish plant and bakery the standard 15 business days to respond with descriptions of corrective actions.

“Please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy,” according to the warning letters. “If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.”

Northern Fish Products Inc. Tacoma, WA
In an April 25 warning letter to company president Ross R. Swanes, the FDA reported it received positive results for Listeria on 22 different swab samples — with nine of them positive for the potentially deadly Listeria monocytogenes — collected from equipment and surfaces in the seafood processing facility at 3911 S. 56th St. in Tacoma.

Northern Fish Co. location FDA inspectors collected the samples Oct. 24 and 25 in 2016, reporting their inspection ran through Nov. 18, 2016.

The positive results for Listeria monocytogenes renders all of the company’s raw, fresh, frozen filleted or portioned fish and ready-to-eat (RTE) products such as imitation crab and hot-smoked fish adulterated and therefore not legal for sale.

“Listeria monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food,” according to the warning letter.

“Consuming food contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.

FDA collected 164 environmental samples. Thirteen were positive for non-pathogenic Listeria and nine were positive for Listeria monocytogenes.

“Specifically, one swab was collected from the legs of the smokehouse finished packing room countertop scale. An employee was observed moving this scale with his hands to the weighing table and then directly touching pieces of finished hot smoked RTE salmon, without washing his hands or changing gloves,” according to the warning letter.

Inspectors also found the Northern Fish Products Inc. processing facility had “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation” in the Federal Code. The violations have to do with the refrigeration policies and procedures for fish and seafood at the processing facility.

“… your firm’s HACCP plan for hot smoked products at the refrigerated storage critical control point for RTE product lists a critical limit of ‘Refrigerated storage temperature must be no greater than ≤40 degrees F for more than (blank) hours’ that is not adequate to control pathogen growth and toxin formation. FDA recommends a critical limit that lists a refrigeration temperature of 40 degrees F or below, which is to be continuous and without a time allotment,” according to the warning letter.

The Northern Fish Products president responded Dec. 6, 2016, to a Form 483 report from FDA regarding the violations at the processing facility. FDA officials found the response inadequate.

“… we are unable to evaluate the adequacy of your corrective actions because the ‘Northern Fish Products Cleaning Schedule’ provided with your response does not describe the cleaning methods, chemicals, and frequency for the cleaning of pallet jacks, fork lifts, or carts,” the warning letter states.

“We acknowledge your response in which you have committed to increased frequency of swab tests on both food contact and non-food contact surfaces, including testing of all drains every (blank). We acknowledge the results you submitted for environmental samples collected at nine locations on Nov. 14, 15, and 16, 2016, which were negative for Listeria.

“Based on FDA’s Listeria findings and observed insanitary conditions, FDA recommends that you consider developing written SSOPs for environmental sampling that define the frequency of sampling, locations for sampling, and the method of sample analysis to verify the success of your sanitation program. We will ascertain the adequacy of your corrective actions during our next inspection.”

Rosemark Bakery Inc. Maplewood, MN
In an April 25 warning letter to Carol A. Rosemark, owner of Rosemary Bakery in the St. Paul suburb of Maplewood, MN, FDA officials detailed numerous “serious violations” of Current Good Manufacturing Practices regulations of the Federal Code.

Rosemark Bakery Inc. warning letterThe problems, observed by FDA inspectors from Dec. 22, 2016, through Jan. 12 this year, include multiple signs of insect infestation; filth and food residue on various surfaces and pieces of food producing equipment; rodent excreta pellets; food ingredients stored on dirty floors; and employees using dirty rags and bar hands to wipe equipment and handle food.

“The foreman used a rag to swab the inside of the divider hopper with soy oil.  After swabbing, the rag was placed on the top of the dough divider which had a build-up of food and oil residue,” according to the warning letter. “The rag was repeatedly dipped in a bucket of soy oil, then used to swab the hopper, and then placed on the filthy divider. Between swabs, raw dough was fed into the dough divider through the hopper.

“Soy oil was running out of the dough divider, creating a pool approximately 6 feet long and 3 feet wide on the floor.  Employees were observed walking through and standing in the pool of soy oil, then walking throughout the production facility.”

The bakery also was in violation of federal regulations regarding food allergens. Some of the products contain wheat, soy, egg, or milk allergens, but, according to FDA, the company does not have any allergen control program in place, such as scheduling production based on allergens, using dedicated equipment, or cleaning between products.

Another major problem was with the bakery’s employees and supervisors who did not wash their hands for hours at a time, although they were handling foods at various stages of production.

“A production employee rolled raw dough in a pan of oats and moved to the packaging room and handled finished bread without washing her hands at any time,” according to the warning letter.

“During a five hour production period employees worked throughout the firm, handled raw ingredients, in-process product, and finished product  without being observed washing their hands.

“The foreman handled donut dough with bare hands. No hand washing was observed over a four hour period he made donuts. During that time period, he was observed touching equipment surfaces that were covered in dried, accumulated food residue, touching unclean non-food contact surfaces such as doors and filing cabinets, and moving between the production room, packaging room, retail area, and basement.”

In addition to filthy conditions through the bakery facility, FDA inspectors noted particularly bad conditions in employee restrooms where “he sink, urinal, and toilet were visibly unclean with brown and black residue throughout, and extensive black residue and was built up on the floor.”


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