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.
Cooperstown Cheese Company LLC
A food firm in New York is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations include the presence of Listeria monocytogenes, mold and more.
Last July, Cooperstown Cheese Company recalled 1,400 pounds of cheese because of positive tests for Listeria monocytogenes contamination.
In a Nov. 24, 2023, warning letter, the FDA described a June 21 through July 28, 2023 inspection of their ready-to-eat (RTE) raw milk cheese manufacturing facility in Milford, NY.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
FDA laboratory analysis of environmental sample #1221906 collected at the firm’s facility on June 21, 2023 confirmed that four of fifty environmental swabs were positive for Listeria monocytogenes, and FDA laboratory analysis of environmental sample #1228986 collected at their facility on June 26, 2023 confirmed that four of fifty-six environmental swabs were positive for Listeria monocytogenes. Of the positive findings, one of the Listeria monocytogenes positive swabs was collected from the food contact surface of a cutting board that was being used to cut RTE Jersey Girl cheese.
Furthermore, dating back to 2017, the firm has had a history of finished product samples that have tested positive for Listeria monocytogenes. In 2017, New York State Department of Agriculture and Markets (NYSDAM) collected a finished product sample of the firm’s Toma Celena cheese (lot #51017) which tested positive for Listeria monocytogenes. In response to this finding, the firm tested (redacted) lots of finished products and found two additional lots (lots #52417 and #60717) to be positive for Listeria monocytogenes.
Whole genome sequencing (WGS) was conducted on the above referenced Listeria monocytogenes isolates. Based on the results of the WGS analysis, the environmental swabs collected at their facility during FDA’s most recent inspection and finished product samples from 2017 represent four different strains of Listeria monocytogenes. None of them matched any clinical isolates. FDA advised them of the importance of these WGS results via a conference call on July 14, 2023, and again on July 20, 2023.
The presence of Listeria monocytogenes in their facility and their products is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. FDA findings indicate that their firm is neither achieving satisfactory control against the presence of Listeria monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
Additionally, FDA has repeatedly detected Listeria innocua, a non-pathogenic Listeria species, in environmental samples collected from their firm during the current and previous FDA inspections. FDA laboratory analysis of environmental samples collected on June 21, 2023 confirmed that three of fifty environmental swabs were positive for Listeria innocua. On June 26, 2023 confirmed that one of fifty-six environmental swabs were positive for Listeria innocua. In 2020, FDA detected Listeria innocua in two environmental swabs (sample #1127382); in 2018, FDA detected Listeria innocua in two environmental swabs including a food contact surface (sample #1082411); and in 2017 FDA detected Listeria innocua in seven environmental swabs (samples #1031962 and #1031963). The presence of Listeria species such as Listeria innocua suggests that conditions are suitable for survival and/or growth of Listeria monocytogenes.
FDA’s response to the findings included, without limitation: voluntary destruction of the lot of cheese that contacted the cutting board that tested positive; voluntarily ceased production; voluntary product recall; discarded cutting boards used directly with cheese that tested positive; cleaned and sanitized all areas that tested positive; cleaned and sanitized the entire cheese making facility including the drying room, (redacted), and brine (redacted); performed environmental swabbing; dedicated a cart for the wheels of cheese being taken from the cheese cave; changed the route to the cheese cave so that they no longer go through the production room; purchased shoe washing stations; marked the perimeter of the indoor/outdoor areas so that employees know where to change shoes and use mat washing station; stopped cutting and vacuum sealing cheese entirely; hired an employee so that they can increase scrubbing and sanitizing frequency; sought the experience of a consultant from (redacted) for expertise in Listeria persistence.
However, given the repeat history of positive Listeria findings in their processing environment and CGMP issues, we are unable to evaluate if they adequately controlled Listeria monocytogenes in their processing facility. FDA continues to be concerned about their ability to maintain a sanitary environment. FDA recommends that they continue to identify potential harborage sites and source(s) of the organism in their processing environment and implement the necessary methods and controls to ensure Listeria monocytogenes does not contaminate their environment or their RTE food products. FDA will verify the effectiveness of their corrective actions and their ability to maintain a sanitary environment during FDA’s next inspection.
Current Good Manufacturing Practice:
1. The firm did not clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food. Specifically, during the inspection, investigators observed the following conditions:
a) Old, white-yellow cheese/wax/salt-like residues from previous lots of cheese were observed on the stainless-steel and plastic tables in their waxing/drying room on June 21 and 26, 2023. These tables were being used to store wheels and blocks of drying cheese products. Thereafter on July 18, 2023, the same residues were observed on these tables. The firm stated they had cleaned and sanitized these tables three times and were unable to remove the residues, but the investigator was able to scrape off the residue from the table.
b) Old, white cheese-like residue from the storage of previous lots of cheese was observed on recently cleaned and sanitized wooden boards in their equipment storage area. In addition, they are storing these cleaned and sanitized boards directly on the floor in the storage area. They use these boards for aging raw milk cheese.
Food residues may harbor and support survival and growth of pathogenic bacteria, which could result in contamination of food.
2. The firm did not clean their non-food-contact surface of equipment in a manner and as frequently as necessary to protect against contamination of food. Specifically, during the inspection, investigators observed the underside of a stainless-steel table in the manufacturing room had a heavy buildup of black-brown mold-like or rust-like residues on its surface. This table is used to store raw milk cheese products.
3. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and kept in repair adequate to prevent food from becoming adulterated. Specifically, during the inspection, investigators observed the following conditions:
a) Areas of black and black-brown mold-like residues on the walls and baseboards in the manufacturing room, where their products are processed. Furthermore, environmental sub #62, which was taken from the floor/wall baseboard (containing these residues) in the manufacturing room on June 26, 2023, was found positive for Listeria monocytogenes.
b) Areas of black and black-brown mold-like substances on the door and around the door handle to the main cheese cave, where their products are aged. Furthermore, environmental sub #57, which was collected from this door handle on June 26, 2023, was found positive for Listeria monocytogenes. It is the firm’s practice, and what FDA directly observed throughout the inspection, to let employees enter and exit the main cheese cave using the door handle without wearing gloves or having to wash hands before entering.
c) Areas of the floor in the manufacturing room, where their products are processed, were pitted, and had uneven and rough surfaces. Furthermore, environmental subs #61 and #91, which were taken from two different floor areas in the manufacturing room on June 26, 2023, were both found positive for Listeria monocytogenes.
d) The bottom of the door, inside the main cheese cave, where their products are aged, was flaking a tape-like material. Furthermore, environmental sub #2, which was collected from this surface on June 21, 2023, was found positive for Listeria monocytogenes.
e) Areas of the floor in the brine area in the main cheese cave, where their products are aged, were pitted, and had uneven and rough surfaces. Furthermore, environmental sub #9, which was collected from this surface on June 21, 2023, was found positive for Listeria monocytogenes.
f) Buildup of water on the floor around the (redacted) near the raw milk receiving room, where they intake the raw cow’s milk that is used to make their products. They stated that the (redacted) has had a “constant leak”, and that this has been an ongoing issue.
g) Areas of black and black-brown mold-like substances and exposed foam-like insulation on the ceiling in the (redacted) cheese cave, which is where their products are aged.
h) A fan in the waxing/drying room that was blowing on cheese product was observed to be covered with a thick layer of dust.
Many of these are repeat observations from previous FDA inspections in 2017, 2018 and 2020.
4. The firm’s equipment and utensils were not designed and were not of such material and workmanship to be adequately cleanable, and were not adequately maintained to protect against contamination. Specifically, during the inspection, investigators observed the following conditions:
a) The rolling stand that holds their curd (redacted) was observed with areas of heavy rusting and chipping paint-like material. The heavy rusting and chipped surface make the rolling stand difficult to adequately cleaned.
b) Multiple wooden boards used for aging raw milk cheese products in the (redacted) cheese aging caves were observed to have uneven surfaces, to be rough cut, and to have knots, frays, and splinters. The knots, frays, and splinters on the uneven and rough surfaces of the boards make the boards difficult to be adequately cleaned.
The full warning letter can be viewed here.
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