WARNING LETTER
Cooperstown Cheese Company, LLC
MARCS-CMS 667551 —
November 24, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Robert C. Sweitzer and Ms. Sharon Tomaselli
Recipient Title
Co-Owners
Cooperstown Cheese Company, LLC
107 Oxbow Road
Milford
,
NY
13807-1131
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
Secondary Issuing Offices
United States
WARNING LETTER
CMS # 667551
11/24/2023
Dear Mr. Sweitzer and Ms. Tomaselli:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) raw milk cheese manufacturing facility located at 107 Oxbow Road., Milford, NY 13807-1131 from June 21 through July 28, 2023. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of
Listeria monocytogenes
(
L. monocytogenes
), a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.
Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the RTE cheese products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
We received your responses to FDA’s environmental sample findings via email on July 13, 17, 18, and 19, and August 3, 2023, and to the FDA-483 via email on August 11, 2023, describing corrective actions taken and planned by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Pathogen Findings
L. 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. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with
L. monocytogenes
can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of environmental sample #1221906 collected at your facility on June 21, 2023 confirmed that four (4) of fifty (50) environmental swabs were positive for
L. monocytogenes
, and FDA laboratory analysis of environmental sample #1228986 collected at your facility on June 26, 2023 confirmed that four (4) of fifty six (56) environmental swabs were positive for
L. monocytogenes
. Of the positive findings, one (1) of the
L. 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, your firm has had history of finished product samples that have tested positive for
L. monocytogenes
. In 2017, New York State Department of Agriculture and Markets (NYSDAM) collected a finished product sample of your firm’s Toma Celena cheese (lot #51017) which tested positive for
L. monocytogenes
. In response to this finding, your firm tested
(b)(4)
lots of finished products and found two additional lots (lots #52417 and #60717) to be positive for
L. monocytogenes
.
Whole genome sequencing (WGS) was conducted on the above referenced
L. monocytogenes
isolates. Based on the results of the WGS analysis, the environmental swabs collected at your facility during FDA’s most recent inspection and finished product samples from 2017 represent four (4) different strains of
L. monocytogenes
. None of them matched any clinical isolates. We advised you of the importance of these WGS results via a conference call on July 14, 2023, and again on July 20, 2023.
The presence of
L. monocytogenes
in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. Appropriate control of
L. 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. Our findings indicate that your firm is neither achieving satisfactory control against the presence of
L. monocytogenes
within your 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
(
L. innocua
), a non-pathogenic
Listeria
species, in environmental samples collected from your firm during the current and previous FDA inspections. FDA laboratory analysis of environmental samples collected on June 21, 2023 confirmed that three (3) of fifty (50) environmental swabs were positive for
L. innocua
and on June 26, 2023 confirmed that one (1) of fifty six (56) environmental swabs were positive for
L. innocua
. In 2020, FDA detected
L. innocua
in two (2) environmental swabs (sample #1127382); in 2018, FDA detected
L. innocua
in two (2) environmental swabs including a food contact surface (sample #1082411); and in 2017 FDA detected
L. innocua
in seven (7) environmental swabs (samples #1031962 and #1031963). The presence of
Listeria
species such as
L. innocua
suggests that conditions are suitable for survival and/or growth of
L. monocytogenes
.
Your 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,
(b)(4)
, and brine
(b)(4)
; 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 you 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 you can increase scrubbing and sanitizing frequency; sought the experience of a consultant from
(b)(4)
for expertise in
Listeria
persistence.
However, given the repeat history of positive
Listeria
findings in your processing environment and CGMP issues, we are unable to evaluate if you adequately controlled
L. monocytogenes
in your processing facility. We continue to be concerned about your ability to maintain a sanitary environment. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure
L. monocytogenes
does not contaminate your environment or your RTE food products. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You 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, as required by 21 CFR § 117.35(d). 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 your 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. You stated you 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 your equipment storage area. In addition, you are storing these cleaned and sanitized boards directly on the floor in the storage area. You 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.
This is a repeat deviation from FDA’s 2018 and 2020 inspections, as investigators observed then that you had not adequately cleaned and sanitized your utensils and equipment.
Your August 11, 2023 response indicated that you consulted with
(b)(4)
and that you “used
(b)(4)
cleaner and successfully removed deposits and strains from all tables.” You also stated that you “found that
(b)(4)
successfully removes salt deposit on aging boards. Ongoing as boards are emptied and recleaned.” In addition, in regard to the cutting boards, your response stated that you discarded all cutting boards used during the inspection and have discontinued “cut and wrap operations until procedures are determined to eliminate the chance of this happening again.” We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
2. You did not clean your non-food-contact surface of equipment in a manner and as frequently as necessary to protect against contamination of food, as required by 21 CFR § 117.35(e). 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.
Your August 11, 2023, response stated “Underside of table was hard cleaned and sanitized.
(b)(4)
sample taken 8/2/23 tested negative for listeria.” However, you have not provided information as to whether or how you will ensure your corrective actions are sustained. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
3. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and kept in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). 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 your 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
L. 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 your products are aged. Furthermore, environmental sub #57, which was collected from this door handle on June 26, 2023, was found positive for
L. monocytogenes
. It is your practice, and what we 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 prior to entering.
c) Areas of the floor in the manufacturing room, where your 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
L. monocytogenes
.
d) The bottom of the door, inside the main cheese cave, where your 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
L. monocytogenes
.
e) Areas of the floor in the brine area in the main cheese cave, where your 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
L. monocytogenes
.
f) Buildup of water on the floor around the
(b)(4)
near the raw milk receiving room, where you intake the raw cow’s milk that is used to make your products. You stated that the
(b)(4)
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
(b)(4)
cheese cave, which is where your 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 the 2017, 2018 and 2020 FDA inspections.
Your August 11, 2023 response stated that you plan to replace the “stained covings the in the
(b)(4)
and drying room” and the door handle to one that is in better condition and more cleanable. You also stated that you repaired the bottom of your brine
(b)(4)
, hard cleaned and sanitized the entire area with
(b)(4)
and took a
(b)(4)
sample that tested negative for
Listeria
. You also stated that you will resurface areas of the floor where pitting has occurred and repair the
(b)(4)
cave walls and ceilings. In addition, you stated that the fan in the wax/drying room was fully cleaned and the water leak in the
(b)(4)
room has been repaired. Furthermore, you stated, “Seam on floor junction from brine
(b)(4)
to main cave was hard cleaned and sanitized with
(b)(4)
and
(b)(4)
.
(b)(4)
sample taken 7/19/23 tested negative for listeria.” However, you have not provided timeframes for when all corrective actions will be completed, and whether and how you will ensure the corrective actions are sustained. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
4. Your 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, as required by 21 CFR § 117.40(a)(1). Specifically, during the inspection, investigators observed the following conditions:
a) The rolling stand that holds your curd
(b)(4)
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
(b)(4)
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.
These are repeat observations from the 2017, 2018 and 2020 FDA inspections.
Your August 11, 2023 response stated that you plan to sand and repaint the curd
(b)(4)
, and replace the wooden boards. We will verify your corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction,
(b)(3)(A)
if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the U.S. Food and Drug Administration, Attention: Michael E. Antaya, Compliance Officer, 32 Hemingway Drive, Riverside, RI 02915 or via email (preferred) to Michael.Antaya@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Mr. Antaya at 401-528-5500 Ext 100 or Michael. Antaya@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
12/26/2023
Regulated Product(s)
Food & Beverages