Now, it is important to point out that an inspection had been done the previous year and that the 2 GMP violations were previously noted. More impactful however, is that during that 2015 inspection, FDA had found 20 samples positive for Listeria. It is also important to note that this audit had been done as a result of a state laboratory finding Listeria in a product sample.
Further, the Listeria was the same strain in all samples "Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015". (Associated Recall)
So while the firm conducted corrective actions (conducted a voluntary recall of ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers in 2015, made changes in the production flow including no longer manufacturing finished ice cream, frozen yogurt, or sorbet on-site (instead just manufacturing frozen flavor bases that are shipped to co-manufacturers, and conducted training for employees), the same organism is still in the facility.
"The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism."A few things to note:
1) This is a reason for facilities to consider using Whole Genome Sequencing (WGS) when they find Listeria in their facility. Too often the assumption is that it is reentering the facility, but it may be worth determining if there is a resident strain.
2) Although this firm went to great lengths to escape the problem, including changing the products they make, they did not solve the fundamental issue of systematic contamination in the facility. Although the facility findings were not huge or overly impactful, that issue still existed and resulted in further scrutiny . WGS had an impact on how FDA evaluated this facility, and making marginal issues bigger than they should have been. Including finding 2 samples of Listeria in the facility.
3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..
4) This points out the long term impact of finding product in the field positive for Listeria. It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.
5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage. Below is an article in the Wall Street Journal countered by an article in Columbus Business First.
FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516395.htm
Jeni's Splendid Ice Creams, LLC 8/9/16
August 9, 2016
John Lowe, IV
President and CEO
Jeni’s Splendid Ice Creams, LLC
401 N. Front Street, Suite 300
Columbus, OH 43215
Warning Letter
CIN-16-492668-20
Dear Mr. Lowe:
The U.S. Food and Drug Administration (FDA) inspected your frozen flavor base manufacturing facility located at 909 Michigan Avenue, Columbus, Ohio on January 25, 2016 through February 9, 2016. 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. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)[1]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your frozen flavor base products 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 been rendered injurious to health. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s responses dated March 2, 2016, April 14, 2016, and April 27, 2016.
Pathogen Findings
FDA’s laboratory analysis of the environmental samples collected on January 26, 2016, confirmed that two (2) of seventy five (75) environmental swabs were positive for L. monocytogenes. Specifically, these positive samples were taken from:
- The floor of the prep room adjacent to the open entryway to the dish room and approximately 9 feet from the prep table where your firm was processing and packaging Intelligentsia Black Cat Espresso Base.
- The floor of the wash room around a drain, which is approximately 2 feet from the three-compartment sink used to wash, rinse, and sanitize equipment parts, utensils, and containers used in production, approximately 3 feet from the shelving unit on which the above items were stored after cleaning, and approximately 3 feet from the (b)(4) used to wash equipment parts used in production.
Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental swabs collected during our April 20, 2015 – April 30, 2015 inspection revealed L. monocytogenes in twenty (20) locations within your facility. This inspection was initiated due to a positive finding of L. monocytogenes in a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. Of the twenty (20) positive samples found during our April 2015 inspection, a number of samples were located in areas adjacent to food contact surfaces including: areas of the (b)(4) used to fill pints of ice cream and areas of the black plastic carts used to move product around the prep and production rooms.
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 the equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming this contaminated food 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.
Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis found that there is one (1) strain of L. monocytogenes present in your facility containing isolates that have been found over a period of time. Specifically, two (2) of the environmental isolates collected January 26, 2016, twenty (20) of the environmental isolates collected April 21, 2015, and two (2) of the finished product isolates from the sample of ice cream collected in April 2015, were identical by WGS analysis.
The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
FDA acknowledges that after our April 2015 findings, your firm took extensive corrective actions including, hiring a sanitation consultant and voluntarily shutting down production on certain dates to deep clean and sanitize your facility. Additionally, FDA acknowledges that in 2015 your firm conducted a voluntary recall of your ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers. Additionally, we acknowledge the changes in your production flow, where your firm no longer manufactures finished ice cream, frozen yogurt, or sorbet on-site. Instead, your firm manufactures frozen flavor bases and ships these bases to co-manufacturers for use in the production of your firm’s brand of finished ice cream and frozen yogurt.
cGMP Violations
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food-contact surfaces, as required by 21 CFR Part 110.20(b)(6). Specifically, during the manufacture of Buttermilk Yogurt Base, Brambleberry Crisp Base, and Intelligentsia Black Cat Espresso Base, our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored. This is a repeat observation from our April 2015 inspection where heavy accumulation of apparent dust and dirt was observed adhering to the guards over the two fans on the evaporator unit located in the dish room where tubs, equipment parts, and utensils used in production were washed, rinsed, sanitized, and stored.
Your firm’s response indicates that you have updated the cleaning procedure in your Master Sanitation Schedule and included air handling units as an environmental sampling site. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.
2. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR Part 110.80. Specifically, our investigator observed an employee in the prep room placing “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers. This is a repeat observation from our April 2015 inspection, where a bag of cocoa powder was observed being handled by an employee in a similar manner.
Your firm’s response indicates that you have updated your Traffic Flow SOP to address the flow of people and materials; added a new SOP to provide additional details and clarify requirements for ingredient transfer; and conducted and documented an employee training on the updated SOP on January 29, 2016 to February 1, 2016. Furthermore, to validate the effectiveness of the training a Manager audited compliance to the new procedure and monitored all shifts in the operation. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliances materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700 Ext. 2163.
Sincerely,
/S/
Steven B. Barber
District Director
Cincinnati District
Wall Street Journal
http://www.wsj.com/articles/jenis-splendid-ice-creams-gets-fda-warning-after-plant-inspections-1472057381
Jeni’s Splendid Ice Creams Gets FDA Warning After Plant Inspections
U.S. agency finds dangerous form of listeria in ice-cream maker’s Columbus, Ohio, facility
By
Jesse Newman
Jeni’s Splendid Ice Creams is still fighting problems with listeria, a potentially deadly bacteria, according to regulators.
In a warning letter to the company’s chief executive, dated Aug. 9, the U.S. Food and Drug Administration said it found a dangerous form of listeria in the company’s Columbus, Ohio, manufacturing plant that supplies the base for Jeni’s ice creams and frozen yogurts.
Regulators also found “significant” violations of good manufacturing practices spelled out in federal regulations during inspections earlier this year.
“Listeria is so widespread in the natural world, it will inevitably find its way into otherwise clean environments,” said Mary Kamm, Jeni’s quality leader. Ms. Kamm said the ice-cream maker tests every batch of frozen product it produces in the Ohio facility and doesn’t distribute it until tests confirm that no listeria is present. Thanks to the company’s sanitation, pathogen testing and other food-safety procedures, she said, “we can assure everyone that the food we produce is absolutely 100% safe.”
The Columbus, Ohio, company operates ice-cream shops in seven states from Missouri to California and sells ice cream at Whole Foods Market Inc. WFM -0.35 % and other retailers throughout the country.
The letter comes more than a year after the ice-cream maker pulled its frozen dessert products from grocery stores because of possible listeria contamination.
According to the FDA, two samples taken by inspectors in Jeni’s Ohio facility during a January inspection tested positive for pathogenic listeria. The samples came from the floor of the prep room where Jeni’s Intelligentsia Black Cat Espresso ice-cream base was being made and from a floor near where utensils and containers were stored.
An inspection last year in the same plant turned up 20 positive samples, after which the company closed its retail stores and voluntarily pulled its frozen-dessert products from supermarkets.
The ice-cream sector has struggled with food safety in recent years. Blue Bell Creameries LP recalled all of its frozen desserts from supermarket shelves last year after the U.S. Centers for Disease Control and Prevention linked its ice cream to three deaths and multiple other illnesses. The company since has resumed sales.
The U.S. Justice Department launched an investigation of Blue Bell’s listeria outbreak. The status of the probe is unclear, and Blue Bell previously has declined to comment. It didn’t immediately respond to a request for comment Wednesday.
According to the FDA’s August warning letter to Jeni’s, the listeria strain found earlier this year matches the one discovered in the plant and the company’s ice cream last year, indicating the potentially deadly pathogen has been present in the facility since 2015.
The FDA said its findings indicate Jeni’s sanitation procedures historically have been insufficient “to control, reduce, or eliminate” listeria from its facility.
The agency’s warning letter pointed to other violations that could lead to food contamination. For example, the FDA said that while bases for Buttermilk Yogurt, Brambleberry Crisp and Intelligentsia Black Cat Espresso were being made, a dust-like substance was present on the fan of a cooling unit mounted in a room where containers and utensils are washed and stored.
Jeni’s responded to the FDA’s concerns in March and April, telling regulators that it had taken steps, such as updating its cleaning procedure, and made plans to sample air units for bacteria. The FDA said it would determine whether these actions were sufficient during its next inspection.
The boutique frozen-dessert company must take “prompt action” to address all violations. The FDA said that if the company fails to do so, it could result in further enforcement actions, such as seizure or injunction.
According to the FDA, Jeni’s took “extensive corrective actions” after its run-in with regulators in 2015, including temporarily ceasing production to perform a deep clean and sanitize the plant and hiring a sanitation consultant. The company also has made production changes since then, making only base flavors in its Ohio plant and shipping them to co-manufacturers for use in ice cream, frozen yogurt and sorbet, the FDA said.
Listeria is a pernicious pathogen that thrives in cool, wet environments. It doesn’t typically cause serious illnesses in healthy people but poses a threat to pregnant women, newborns, older adults and people with weakened immune systems.
3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..
4) This points out the long term impact of finding product in the field positive for Listeria. It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.
5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage. Below is an article in the Wall Street Journal countered by an article in Columbus Business First.
FDA Warning Letter
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516395.htm
Jeni's Splendid Ice Creams, LLC 8/9/16
August 9, 2016
John Lowe, IV
President and CEO
Jeni’s Splendid Ice Creams, LLC
401 N. Front Street, Suite 300
Columbus, OH 43215
Warning Letter
CIN-16-492668-20
Dear Mr. Lowe:
The U.S. Food and Drug Administration (FDA) inspected your frozen flavor base manufacturing facility located at 909 Michigan Avenue, Columbus, Ohio on January 25, 2016 through February 9, 2016. 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. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)[1]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your frozen flavor base products 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 been rendered injurious to health. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s responses dated March 2, 2016, April 14, 2016, and April 27, 2016.
Pathogen Findings
FDA’s laboratory analysis of the environmental samples collected on January 26, 2016, confirmed that two (2) of seventy five (75) environmental swabs were positive for L. monocytogenes. Specifically, these positive samples were taken from:
- The floor of the prep room adjacent to the open entryway to the dish room and approximately 9 feet from the prep table where your firm was processing and packaging Intelligentsia Black Cat Espresso Base.
- The floor of the wash room around a drain, which is approximately 2 feet from the three-compartment sink used to wash, rinse, and sanitize equipment parts, utensils, and containers used in production, approximately 3 feet from the shelving unit on which the above items were stored after cleaning, and approximately 3 feet from the (b)(4) used to wash equipment parts used in production.
Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes. Environmental swabs collected during our April 20, 2015 – April 30, 2015 inspection revealed L. monocytogenes in twenty (20) locations within your facility. This inspection was initiated due to a positive finding of L. monocytogenes in a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. Of the twenty (20) positive samples found during our April 2015 inspection, a number of samples were located in areas adjacent to food contact surfaces including: areas of the (b)(4) used to fill pints of ice cream and areas of the black plastic carts used to move product around the prep and production rooms.
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 the equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming this contaminated food 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.
Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis found that there is one (1) strain of L. monocytogenes present in your facility containing isolates that have been found over a period of time. Specifically, two (2) of the environmental isolates collected January 26, 2016, twenty (20) of the environmental isolates collected April 21, 2015, and two (2) of the finished product isolates from the sample of ice cream collected in April 2015, were identical by WGS analysis.
The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
FDA acknowledges that after our April 2015 findings, your firm took extensive corrective actions including, hiring a sanitation consultant and voluntarily shutting down production on certain dates to deep clean and sanitize your facility. Additionally, FDA acknowledges that in 2015 your firm conducted a voluntary recall of your ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers. Additionally, we acknowledge the changes in your production flow, where your firm no longer manufactures finished ice cream, frozen yogurt, or sorbet on-site. Instead, your firm manufactures frozen flavor bases and ships these bases to co-manufacturers for use in the production of your firm’s brand of finished ice cream and frozen yogurt.
cGMP Violations
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food-contact surfaces, as required by 21 CFR Part 110.20(b)(6). Specifically, during the manufacture of Buttermilk Yogurt Base, Brambleberry Crisp Base, and Intelligentsia Black Cat Espresso Base, our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored. This is a repeat observation from our April 2015 inspection where heavy accumulation of apparent dust and dirt was observed adhering to the guards over the two fans on the evaporator unit located in the dish room where tubs, equipment parts, and utensils used in production were washed, rinsed, sanitized, and stored.
Your firm’s response indicates that you have updated the cleaning procedure in your Master Sanitation Schedule and included air handling units as an environmental sampling site. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.
2. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR Part 110.80. Specifically, our investigator observed an employee in the prep room placing “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers. This is a repeat observation from our April 2015 inspection, where a bag of cocoa powder was observed being handled by an employee in a similar manner.
Your firm’s response indicates that you have updated your Traffic Flow SOP to address the flow of people and materials; added a new SOP to provide additional details and clarify requirements for ingredient transfer; and conducted and documented an employee training on the updated SOP on January 29, 2016 to February 1, 2016. Furthermore, to validate the effectiveness of the training a Manager audited compliance to the new procedure and monitored all shifts in the operation. We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliances materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700 Ext. 2163.
Sincerely,
/S/
Steven B. Barber
District Director
Cincinnati District
Wall Street Journal
http://www.wsj.com/articles/jenis-splendid-ice-creams-gets-fda-warning-after-plant-inspections-1472057381
Jeni’s Splendid Ice Creams Gets FDA Warning After Plant Inspections
U.S. agency finds dangerous form of listeria in ice-cream maker’s Columbus, Ohio, facility
By
Jesse Newman
Jeni’s Splendid Ice Creams is still fighting problems with listeria, a potentially deadly bacteria, according to regulators.
In a warning letter to the company’s chief executive, dated Aug. 9, the U.S. Food and Drug Administration said it found a dangerous form of listeria in the company’s Columbus, Ohio, manufacturing plant that supplies the base for Jeni’s ice creams and frozen yogurts.
Regulators also found “significant” violations of good manufacturing practices spelled out in federal regulations during inspections earlier this year.
“Listeria is so widespread in the natural world, it will inevitably find its way into otherwise clean environments,” said Mary Kamm, Jeni’s quality leader. Ms. Kamm said the ice-cream maker tests every batch of frozen product it produces in the Ohio facility and doesn’t distribute it until tests confirm that no listeria is present. Thanks to the company’s sanitation, pathogen testing and other food-safety procedures, she said, “we can assure everyone that the food we produce is absolutely 100% safe.”
The Columbus, Ohio, company operates ice-cream shops in seven states from Missouri to California and sells ice cream at Whole Foods Market Inc. WFM -0.35 % and other retailers throughout the country.
The letter comes more than a year after the ice-cream maker pulled its frozen dessert products from grocery stores because of possible listeria contamination.
According to the FDA, two samples taken by inspectors in Jeni’s Ohio facility during a January inspection tested positive for pathogenic listeria. The samples came from the floor of the prep room where Jeni’s Intelligentsia Black Cat Espresso ice-cream base was being made and from a floor near where utensils and containers were stored.
An inspection last year in the same plant turned up 20 positive samples, after which the company closed its retail stores and voluntarily pulled its frozen-dessert products from supermarkets.
The ice-cream sector has struggled with food safety in recent years. Blue Bell Creameries LP recalled all of its frozen desserts from supermarket shelves last year after the U.S. Centers for Disease Control and Prevention linked its ice cream to three deaths and multiple other illnesses. The company since has resumed sales.
The U.S. Justice Department launched an investigation of Blue Bell’s listeria outbreak. The status of the probe is unclear, and Blue Bell previously has declined to comment. It didn’t immediately respond to a request for comment Wednesday.
According to the FDA’s August warning letter to Jeni’s, the listeria strain found earlier this year matches the one discovered in the plant and the company’s ice cream last year, indicating the potentially deadly pathogen has been present in the facility since 2015.
The FDA said its findings indicate Jeni’s sanitation procedures historically have been insufficient “to control, reduce, or eliminate” listeria from its facility.
The agency’s warning letter pointed to other violations that could lead to food contamination. For example, the FDA said that while bases for Buttermilk Yogurt, Brambleberry Crisp and Intelligentsia Black Cat Espresso were being made, a dust-like substance was present on the fan of a cooling unit mounted in a room where containers and utensils are washed and stored.
Jeni’s responded to the FDA’s concerns in March and April, telling regulators that it had taken steps, such as updating its cleaning procedure, and made plans to sample air units for bacteria. The FDA said it would determine whether these actions were sufficient during its next inspection.
The boutique frozen-dessert company must take “prompt action” to address all violations. The FDA said that if the company fails to do so, it could result in further enforcement actions, such as seizure or injunction.
According to the FDA, Jeni’s took “extensive corrective actions” after its run-in with regulators in 2015, including temporarily ceasing production to perform a deep clean and sanitize the plant and hiring a sanitation consultant. The company also has made production changes since then, making only base flavors in its Ohio plant and shipping them to co-manufacturers for use in ice cream, frozen yogurt and sorbet, the FDA said.
Listeria is a pernicious pathogen that thrives in cool, wet environments. It doesn’t typically cause serious illnesses in healthy people but poses a threat to pregnant women, newborns, older adults and people with weakened immune systems.
Columbus Business First
Jeni's listeria response: Ice cream is 'absolutely 100 percent safe'
Aug 24, 2016, 4:53pm EDT Updated Aug 24, 2016, 5:05pm EDT
Though the FDA discovered listeria again at Jeni’s Splendid Ice Creams, the company said the issue has been dealt with and its products are safe.
“To control listeria, the best food production companies are constantly searching for it through environmental swabbing and then eradicating it before it has the chance to spread to any food contact surfaces,” the company noted in a Wednesday blog post jointly credited to founder Jeni Britton Bauer, CEO John Lowe and Quality Leader Mary Kamm. “That is how a good listeria control program works; that is how ours is working.”
The U.S. Food and Drug Administration discovered the bacteria during inspections that occurred in January and February of this year at the company’s 909 Michigan Ave. facility. The FDA issued a warning letter Aug. 9 to the Columbus company, detailing the violations that became public Wednesday afternoon.
Two of 75 samples were found to have listeria by the FDA’s lab. Those two samples came from:
- The floor adjacent to the prep room, nine feet from a prep table where the base for Intelligentsia Black Cat Espresso was being processed and packaged.
- The floor of the wash room by a drain, two feet from a sink used to wash, rinse and sanitize equipment parts, utensils and containers used in production.
Jeni’s said it took immediate corrective actions and prevented any spread to food contact surfaces or areas around food contact surfaces. It also noted that it has taken more than 2,000 environmental swabs in the past year and listeria has never been detected on food contact surfaces or around food contact surfaces and that its “test-and-hold” procedures, which have been in place for a year, have not turned up a single positive test for listeria.
“As a result of our sanitation and other food safety procedures, our environmental testing program and our test-and-hold procedures, we can assure everyone that the food we produce is absolutely 100 percent safe,” the company wrote. “Beyond that, we want to clarify that the periodic detection of listeria on non-food contact surfaces is not in any way abnormal in the industry or indicative of an ‘outbreak’ of listeria.”
In the wake of last year’s listeria issues, which led to a multi-million dollar product recall and a prolonged sales shutdown, the company reconfigured its production to use the Michigan Avenue facility to produce ingredients and bases only while final ice cream production is handled by third-party partners.
The FDA letter notes that the inspection in April 2015 found listeria at 20 sites in the facility including on the spout of a machine used to fill pints.
Listeria also was discovered in two pints of ice cream tested by the Nebraska Department of Agriculture, which was the incident that spurred the initial recall.
Through an analysis called Whole Genome Sequencing, the FDA determined that the listeria found in January is the same strain discovered last year.
“Listeria is combated by constantly searching for it,” the company said. “When food production companies look hard enough, often enough, they will find listeria in their food production facilities. Listeria is so widespread in the natural world, it will inevitably find its way into otherwise clean environments.”
The FDA also noted two violations of good manufacturing processes for food including a “dust-like” material on a fan guard and on the underside of a cooling unit and allowing the outside of bags of sugar make contact with the inside of the containers into which the sugar was being transferred.
The letter indicates that Jeni’s, in correspondence with the FDA earlier this year, has updated cleaning procedures for air handling units and for ingredient transfer in the building.
“We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection,” the FDA wrote.
Jeni's has 23 stores in seven states while also selling through grocers, boutique retailers and through its website.
Dan Eaton covers retailing and restaurants for Columbus Business First.
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