Basically, FDA found a lot of issues that indicate this facility just doesn't get it.
- LM was all over the plant, on food contact equipment, and on product.
- While the plant did testing and found Listeria species, they did NOTHING beyond re-clean the area. They did not do follow-up testing nor did they try to determine where the Listeria was coming from, whether is was LM, or whether it impacted product.
- They followed poor sanitary practices including not properly washing hands
- Poor cleaning of facility and equipment
- Poor design and maintenance of the facility
It is amazing that this product had as wide of distribution as it did. It is also amazing that no one advised them otherwise or inspected them with an eye on safety. Was it arrogance that being a small, close-to-the-farm, boutique artisan cheese shop, they were beyond the rules or the need to understand the rules? Pathogens don't read the press clippings and don't care about whether a facility is big or small, organic or conventional, or that it is considered artisan.
FDA Investigation Report (FDA - 483)
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm554717.pdf
Vulto Creamery, Walton, NY
FDA Investigation Report (FDA - 483)
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm554717.pdf
Vulto Creamery, Walton, NY
Date of Inspection 2/28/17 to 3/22/17
OBSERVATION 1
Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Specifically:
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
Specifically, a review of your environmental sampling test records noted the following:
The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Specifically, review of your environmental sampling results across 20 months from 7/28/2014 through 2/19/2017 showed positive results for Listeria species on several food contact and non-food contact surfaces in your facility. Per your documented corrective actions, upon getting a positive result you re-cleaned and re-sanitized the affected areas using your routine cleaning and sanitizing operations. However, when you re-sampled these locations a month or more later and tests showed repeated positive results, you did not investigate the use of a more effective method of cleaning and sanitizing.
OBSERVATION 4
Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.
Specifically, you are storing wood boards that have been cleaned and sanitized in your facility attic, where exposed insulation and other debris were observed. Your ready-to-eat Hamden, Blais Blue, Andes and Walton Umber cheese products sit directly on these boards during the aging process.
Additionally, you stated that the attic gets very hot during the summer months, and that it can take approximately- for the wood boards to completely dry.
OBSERVATION 5
Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms and foreign substances.
Specifically, on 3/1/2017 the following was observed during the manufacturing of your Walton Umber hard cheese product:
The design and materials of equipment does not allow proper cleaning and maintenance.
Specifically, a large majority of the wooden boards used for aging in the cheese aging room are of a design that does not allow them to be appropriately cleaned and sanitized. The boards, which you stated are made from- have uneven surfaces, are rough cut, and have knots, frays, and splinters, which allows for the collection of moisture and debris, representing a potential haborage area for filth and microorganisms. These wooden boards come in direct contact with your aging Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products.
OBSERVATION 7
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces.
Specifically, on 3/1/2017, condensation was noted dripping from the horizontal stainless steel bar on the cheese press directly onto the food contact surface of the draining table below. This table is used to allow molded cheese products to drain off whey. Additionally, rust-like particles were noted in the condensation puddle on the table.
OBSERVATION 8
Employees did not sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.
Specifically, during the inspection on 3/1/2017, it was observed that you and your employee did not sanitize your hands or arms prior to using them to stir and break up the in-process Walton Umber cheese curds.
OBSERVATION 9
Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated.
Specifically, the following was observed throughout the inspection:
Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.
Specifically, during the inspection, the following was observed:
Lack of an automatic temperature alarm system for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.
Specifically, your firm's cheese aging room and walk-in cooler lack an automatic temperature alarm system that would provide indication that a significant temperature change occurred. Your finished cheese products are stored in the cheese aging room.
Additionally, you stated that you do not calibrate and never have calibrated the thermometers located in the cheese aging room and walk-in cooler.
OBSERVATION 12
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Specifically, throughout the inspection the following was observed:
Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.
Specifically, during the inspection on 2/28/2017, a long piece of sticky fly tape, heavily populated with dead insects, observed hanging directly over exposed, uncovered ready-to-eat cheese products in your cheese aging room was pointed out to you. This fly tape was observed hanging in the cheese aging room in the same condition on 3/1/2017 and 3/712017.
OBSERVATION 14
Plumbing constitutes a source of contamination to equipment and utensils.
Specifically, during the inspection the following was observed:
OBSERVATION 15
You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food.
Specifically, you were notified via telephone on 3/3/2017 that your film's Ouleout soft raw milk cheese product bearing lot #617 was found to be positive for Listeria monocytogenes, a foodbome pathogen, and that you would need to file a repo1table food repo1t to the FDA within 24 hours. At this present time, you still have not filed a repo1table food report with the FDA.
*DATES OF INSPECTION
2/28/2017(Tue),3/01/2017(Wed),3/02/2017(Thu),3/07/2017(Tue),3/13/2017(Mon),3/17/2017(Fri),3/22/ 2017(Wed)
OBSERVATION 1
Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Specifically:
- A finished product sample of your firm' s Ouleout soft raw milk cheese product bearing lot #617 was analyzed by an FDA laboratory and found to be positive for Listeria monocytogenes, a foodbome pathogen.
- A finished product sample of your film's Ouleout soft raw milk cheese product bearing lot #623, collected by the New York State Department of Agriculture and Markets in your facility on
- 2/28/2017 during the FDA inspection, was found to be positive for Listeria monocytogenes, a foodbome pathogen.
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
Specifically, a review of your environmental sampling test records noted the following:
- You have conducted environmental sampling during 20 months from 7/28/2014 through
- 2/19/2017. Your records show 54 out of 198 results positive for Listeria spp. taken from various locations throughout your manufacturing facility, which include, but are not limited to: floor drains in the manufacturing room, wash room and cheese aging room; outside of brine tanks in the walk-in cooler; door handles to the cheese aging room, walk-in cooler and entry door; various areas of the floor in the cheese aging room; bottom of a squeegee in the cheese aging room; employee aprons; and wooden cheese rack dollies in the cheese aging room. The most recent positive finding being a swab taken from the floor in the manufacturing room on 2/19/2017. You have not conducted an investigation to provide identification of the Listeria spp. to Genus and species and you have also failed to identify its source or point of entry/harborage in your facility.
- A total of 10 of the 54 positive results were found on food contact surfaces between 10/30/2014 and 4/28/2015. You did not conduct microbial testing of finished products to confirm that your finished products were not contaminated with the organism found by your environmental testing program. According to your sample records, the food contact surface locations were as follows:
- Wooden cheese aging board in cheese aging room; positive result from 10/30/2014.
- The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden cheese aging boards in cheese aging room; positive results from 12/3/2014.
- The cheese brush used to brush Ouleout and Miranda soft cheeses and two wooden cheese aging boards in cheese aging room; positive results from 1/6/2015.
- Two cheese brush used to brush the Andes and the Walton Umber hard cheeses; positive results from 2/3/2015.
- Two cheese brush used to brush the Andes and the Walton Umber hard cheeses; positive results from 3/22/2015.
- A cheese brush (not specified to product); positive result from 4/28/2015.
- You did not continue sampling food contact surfaces after 4/28/2015 to determine if Listeria spp. was still present on these surfaces representing a continued contamination risk to your cheese products.
- Upon finding a Listeria spp. positive result on a surface, you re-cleaned and re-sanitized the area, but did not re-swab that location until a month or more later, after additional lots of cheese had been produced, to determine if your cleaning and sanitizing was effective and to determine if the Listeria spp. was still present.
The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Specifically, review of your environmental sampling results across 20 months from 7/28/2014 through 2/19/2017 showed positive results for Listeria species on several food contact and non-food contact surfaces in your facility. Per your documented corrective actions, upon getting a positive result you re-cleaned and re-sanitized the affected areas using your routine cleaning and sanitizing operations. However, when you re-sampled these locations a month or more later and tests showed repeated positive results, you did not investigate the use of a more effective method of cleaning and sanitizing.
OBSERVATION 4
Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.
Specifically, you are storing wood boards that have been cleaned and sanitized in your facility attic, where exposed insulation and other debris were observed. Your ready-to-eat Hamden, Blais Blue, Andes and Walton Umber cheese products sit directly on these boards during the aging process.
Additionally, you stated that the attic gets very hot during the summer months, and that it can take approximately- for the wood boards to completely dry.
OBSERVATION 5
Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms and foreign substances.
Specifically, on 3/1/2017 the following was observed during the manufacturing of your Walton Umber hard cheese product:
- You and your employee were observed placing your bare hands and arms, up to your elbows, directly into the cheese making vat in order to manually break up recently formed cheese curds. Although you washed your hands, neither of you washed your lower or upper arms. Additionally, your employee was observed to have multiple cuts and abrasions on his aims, which came in direct contact with cheese curds and whey.
- A stainless steel ladle, used to scoop milk for pH analysis, had buildup of a rust-like substance on its inner surface. You stated you use this same ladle in the same manner during the manufacturing of all cheese products.
The design and materials of equipment does not allow proper cleaning and maintenance.
Specifically, a large majority of the wooden boards used for aging in the cheese aging room are of a design that does not allow them to be appropriately cleaned and sanitized. The boards, which you stated are made from- have uneven surfaces, are rough cut, and have knots, frays, and splinters, which allows for the collection of moisture and debris, representing a potential haborage area for filth and microorganisms. These wooden boards come in direct contact with your aging Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products.
OBSERVATION 7
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces.
Specifically, on 3/1/2017, condensation was noted dripping from the horizontal stainless steel bar on the cheese press directly onto the food contact surface of the draining table below. This table is used to allow molded cheese products to drain off whey. Additionally, rust-like particles were noted in the condensation puddle on the table.
OBSERVATION 8
Employees did not sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.
Specifically, during the inspection on 3/1/2017, it was observed that you and your employee did not sanitize your hands or arms prior to using them to stir and break up the in-process Walton Umber cheese curds.
OBSERVATION 9
Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated.
Specifically, the following was observed throughout the inspection:
- Heavy buildup of apparent rust-like substance on the white painted vertical support bars that hold the cheese presses in place. These bars are located directly over the draining table closest to the window in the manufacturing room; flakes of this rust-like substance were observed on the top surface of the drain table where molds of cheese are set to drain.
- Heavy buildup of apparent rist-like substance on painted white metal storage shelf in wash room. This shelf is used to store cheese molds and other equipment and utensils.
- A heavy buildup of apparent black and green mold-like substance was noted on the cement walls in the manufacturing room and wash room. Several cleaning brushes, storage racks and cheese molds were noted to come in direct contact with these walls. Additionally, these walls were moist from condensation.
- Heavy buildup of rust-like and black mold-like substance on stainless steel storage shelf in walk-in cooler. This shelf was being used to hold boxes of wrapped finished cheese products.
- A large piece of ceiling tile was missing in the cheese aging room. Uncovered, ready-to-eat cheese was being stored directly below this area.
- The exhaust fan on the ceiling in the manufacturing room has a buildup of dirt-like and mold-like substances. This fan is directly above a stainless steel draining table where molded cheeses are placed to drain whey.
Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.
Specifically, during the inspection, the following was observed:
- On 3/2/2017, a fan in the attic that was in operation to dry cleaned and sanitized wood boards regularly used for cheese aging was noted to have dirt and dust debris buildup on the spinning arms and face of the fan. These wood boards come in direct contact with Hamden, Blais Blue, Walton Umber and Andes ready-to-eat cheese products during the aging process in the cheese aging room.
- On 2/28/2017, a fan in the manufacturing room was noted to have a very heavy buildup of unknown debris on the spinning arms and face of the fan. You stated your furn uses this fan to help dry the floor in the manufacturing room after cleaning.
Lack of an automatic temperature alarm system for each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms.
Specifically, your firm's cheese aging room and walk-in cooler lack an automatic temperature alarm system that would provide indication that a significant temperature change occurred. Your finished cheese products are stored in the cheese aging room.
Additionally, you stated that you do not calibrate and never have calibrated the thermometers located in the cheese aging room and walk-in cooler.
OBSERVATION 12
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Specifically, throughout the inspection the following was observed:
- The concrete floors in the manufacturing room and cheese aging room were noted to be cracked and pitted; an accumulation of moisture was noted to be stuck in the cracks and pits of the floor. A buildup of apparent black mold-like substance was noted on the window sill in the wash room . There is an uneven layer of concrete/mortar· around the- in the manufacturing room. There are also cracks where the mortar meets thô€€‡port
- The door to the manufacturing room does not have a door handle, but instead has plastic packing tape covering part of the hole.
- The walk-in cooler door does not have a door handle, but instead has a duty cloth rag plugging up the hole.
- A heavy buildup of rust-like debris was noted on the lower part of the manufacturing room door. There was buildup of a black mold-like substance on the wall between the walk-in cooler and cheese aging room.
- A hole was noted at the bottom of the wall near the foot bath in the packaging room .
- A black mold-like substance was observed on the ceiling in the packaging room, near the wash room entrance.
Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.
Specifically, during the inspection on 2/28/2017, a long piece of sticky fly tape, heavily populated with dead insects, observed hanging directly over exposed, uncovered ready-to-eat cheese products in your cheese aging room was pointed out to you. This fly tape was observed hanging in the cheese aging room in the same condition on 3/1/2017 and 3/712017.
OBSERVATION 14
Plumbing constitutes a source of contamination to equipment and utensils.
Specifically, during the inspection the following was observed:
- A hose with a nozzle on the end was directly connected to the potable water supply in the manufacturing room without a proper backflow prevention device installed. This hose is used during cleaning operations.
- A hose with a nozzle on the end was directly connected to the potable water supply in the wash room without a proper backflow prevention device installed. This hose is used during cleaning operations.
- The drain pipe from the 3-basin sink in the manufacturing room is approximately 2.5 inches wide. The air gap between the drain pipe and the waste funnel is only 1.5 inches, which does not provide an adequate air gap between your sink drain and waste pipe.
- The wash room 3-basin sink does not have an air gap installed between the sink drain pipe and the waste pipe.
OBSERVATION 15
You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food.
Specifically, you were notified via telephone on 3/3/2017 that your film's Ouleout soft raw milk cheese product bearing lot #617 was found to be positive for Listeria monocytogenes, a foodbome pathogen, and that you would need to file a repo1table food repo1t to the FDA within 24 hours. At this present time, you still have not filed a repo1table food report with the FDA.
*DATES OF INSPECTION
2/28/2017(Tue),3/01/2017(Wed),3/02/2017(Thu),3/07/2017(Tue),3/13/2017(Mon),3/17/2017(Fri),3/22/ 2017(Wed)
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