A California avocado packing house is recalling avocados "due to positive test results on environmental samples taken during a routine government inspection at its California packing facility." Henry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores.
"The recalled products – California-grown conventional and organic avocados -- were packed at Henry Avocado’s packing facility in California and distributed in Arizona, California, Florida New Hampshire, North Carolina and Wisconsin. All shipments from the packing facility are subject to the recall (Henry Avocado did not begin packing there until late January 2019). Avocados imported from Mexico and distributed by Henry Avocado are not subject to the recall and may continue to be sold and consumed."
Is the risk high? Hard to tell because we don't know whether the avocados themselves were contaminated and if so, to what degree the contaminate on the outside of the avocado would be transferred to the internal flesh. The concern is that someone making a product like guacamole would not properly wash the avocado and the contaminate would be transferred to the internal flesh as the person sliced and prepared the guacamole. The potential for growth increases risk as the guacamole is more neutral in pH and would not inhibit growth. Long storage even at refrigeration temperature also increases risk in that Listeria can grow at refrigeration temperatures albeit slower than if the product were temperature abused.
https://www.fda.gov/Safety/Recalls/ucm634230.htm
Henry Avocado Recalls Whole Avocados Because Of Possible Health Risk
For Immediate Release
March 23, 2019
Showing posts with label environmental control. Show all posts
Showing posts with label environmental control. Show all posts
Sunday, March 24, 2019
Thursday, March 9, 2017
CDC Report - 2016 Salmonella Outbreak in Children Associated with Playground Sand
A 2016 Salmonella outbreak in Madrid, Spain caused illness in 24 preschool students, aged 3 to 5 years old. It was concluded that the source of the Salmonella was the sand in the playground. The Salmonella likely got there through bird droppings.
While these types of issues may be difficult to prevent, there are some preventive measures that can be taken. Keeping children from putting their hands in their mouth when playing in the dirt. (Good luck with that). Having kids wash their hands after playing. Recognizing that bird droppings are a potential source of Salmonella, so placing sandboxes in areas away from trees and other overhead structures where birds may land (and poop). Sure, trees provide shade, and in Spain, it is probably better to be in the shade. However, structures such as large umbrellas may be used. Umbrellas or other movable structures can be beneficial in allowing the sand to dry.
CDC - MMWR
https://www.cdc.gov/mmwr/volumes/66/wr/mm6609a3.htm?s_cid=mm6609a3_e
Notes from the Field: An Outbreak of Salmonella Typhimurium Associated with Playground Sand in a Preschool Setting — Madrid, Spain, September–October 2016
Weekly / March 10, 2017 / 66(9);256–257
CDC - MMWR
https://www.cdc.gov/mmwr/volumes/66/wr/mm6609a3.htm?s_cid=mm6609a3_e
Notes from the Field: An Outbreak of Salmonella Typhimurium Associated with Playground Sand in a Preschool Setting — Madrid, Spain, September–October 2016
Weekly / March 10, 2017 / 66(9);256–257
Monday, January 16, 2017
FDA Releases Draft Guidance: Control of Listeria monocytogenes in Ready-To-Eat Foods
FDA released its Draft Guidance for the control of Listeria monocytogenes in RTE foods. This document applies to facilities that are subject to the Preventive Controls as well as smaller firms only subject to cGMPs. This document is open for comments before becoming finalized.
This is a necessary read for any FDA regulated company producing RTE product where there is exposure of the product to the environment before packaging. This document discusses control, environmental monitoring, and corrective action. While less prescriptive than the earlier version (it puts more responsibility on the processor for determining risk), it is more aggressive in terms of expected controls and monitoring.
The guidance does differentiate high risk from low risk product (low risk will not support more than one log of growth), and this impacts the monitoring regiment as well as corrective action, although both low risk and high risk product require both monitoring and corrective action.
The guidance discusses product formulating for control of Listeria where that formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and processes that are considered Listeria reduction must reduce by 5 logs.
Environmental monitoring should cover both food contact surfaces (FCS) and non-food contact surfaces (non-FCS) and they recommend Listeria ssp. FDA suggests 5 FCS and 5 non-FCS taken several hours into production. This is more aggressive than doing pre-operational swabs. They suggest a sampling frequency of monthly for low risk products and weekly for high risk products.
There is a lengthy discussion on corrective actions should an environmental sample be found positive, but much of this, as they point out, is dependent upon the particulars of the facility and the product. This passage is important to point out:
Please contact us if you have any questions on this document.
This is a necessary read for any FDA regulated company producing RTE product where there is exposure of the product to the environment before packaging. This document discusses control, environmental monitoring, and corrective action. While less prescriptive than the earlier version (it puts more responsibility on the processor for determining risk), it is more aggressive in terms of expected controls and monitoring.
The guidance does differentiate high risk from low risk product (low risk will not support more than one log of growth), and this impacts the monitoring regiment as well as corrective action, although both low risk and high risk product require both monitoring and corrective action.
The guidance discusses product formulating for control of Listeria where that formulation must limit the growth of Listeria to less than one log. It also discusses reduction processes, and processes that are considered Listeria reduction must reduce by 5 logs.
Environmental monitoring should cover both food contact surfaces (FCS) and non-food contact surfaces (non-FCS) and they recommend Listeria ssp. FDA suggests 5 FCS and 5 non-FCS taken several hours into production. This is more aggressive than doing pre-operational swabs. They suggest a sampling frequency of monthly for low risk products and weekly for high risk products.
There is a lengthy discussion on corrective actions should an environmental sample be found positive, but much of this, as they point out, is dependent upon the particulars of the facility and the product. This passage is important to point out:
"As discussed in section II.C, L. monocytogenes is widespread in the environment, has been isolated from food packing and processing environments, and has been shown to persist in equipment and the processing environment in harborage sites. As a result, you should expect to detect the presence of Listeria spp. or L. monocytogenes on an occasional basis in environmental samples collected from your plant. As discussed in section XIII.A, the goals of an environmental monitoring program include finding L. monocytogenes and harborage sites if present in your plant and ensuring that corrective actions have eliminated L. monocytogenes and harborage sites when found in your plant. If you consistently see negative test results in environmental samples collected from your plant, we recommend that you revise your environmental monitoring procedures to add, substitute, or both add and substitute other surfaces in your plant for sample collection and testing to ensure you are not missing a source of contamination."There is also a section on finished product testing.
Please contact us if you have any questions on this document.
Thursday, July 28, 2016
Warning Letter Indicates Facility has Same Listeria Strains in Plant for Years
In an FDA Warning Letter recently issued to Resers Fine Foods in relation to investigation conducted around Listeria issues in 2013 and 2016, FDA indicated that they found the same strain in the facility. This shows the difficulty in getting rid of Listeria in the environment, and the need to continuously control that environment, especially once LM is found.
From that Warning Letter:
From that Warning Letter:
"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 samples (FDA 821317 and FDA 821318) collected during our 2013 inspection revealed L. monocytogenes in six (6) environmental subsample swabs in various locations within your facility, including in floor gaps, wheels of forklift and carts that are moved throughout the facility, and floor drains. Additionally, an environmental sample (FDA 862365) collected during our 2014 inspection revealed L. monocytogenes in two (2) environmental subsample swabs in locations within your facility, including on the wheel of a fork lift and v-mag number.
Whole Genome Sequencing (WGS) analysis was conducted on six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2015, two (2) L. monocytogenes isolates obtained from the FDA environmental samples collected in August 2014, and six (6) L. monocytogenes isolates obtained from the FDA environmental samples collected in November 2013. 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 are at least three (3) different strains of L. monocytogenes present in the facility. The WGS results show that one (1) of these strains includes isolates that have been found over a period of time. Specifically, four (4) of the environmental isolates collected in November 2015, one (1) of the environmental isolates collected in August 2014, and four (4) of the environmental isolates collected in November 2013, were identical by WGS analysis.
The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since November 2013. The reoccurring presence of identical strains 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.
Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, humans or machinery can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. FDA acknowledges that one of the environmental swabs from the November 2015 inspection that tested positive for L. monocytogenes was taken from a food contact surface used to carry potato salad. As a result of this finding, your firm conducted a voluntary recall on December 1, 2015 of a single lot of potato salad product."
Thursday, July 9, 2015
Blue Bell to Conduct Trial Production Run in AL Facility
After ceasing operations in April / May to clean up their operation in light of product being linked to cases of Listeriosis, Blue Bell Ice Cream will run a trial production run in their Alabama facility.
The costs of this contamination event will be tremendous. First and foremost, are the people who contracted Listeria and their associated costs. Then the legal fees. The cost to the people who were laid off or furloughed (roughly 1,400 in each category). The company also has the cost of the recall and the lost revenues for 4 months of product. Then there will be costs associated with resuming production....costs of improvements to the operation, retraining of employees, conducting trial runs, etc. Getting back into the market place will not be cheap....regaining freezer shelf-space (you don't think those retailers let that space go empty for 4 months), restarting a distribution system, etc. And then regaining sales....the loyal will be back, but many other will be hesitant or leery, while others have moved on to other brands....the lost customer is very difficult, if not impossible to recover.
And what if they find it again....certainly this has been the case in a number of facility-related contamination events......
CBS DFW
http://dfw.cbslocal.com/2015/07/08/blue-bell-to-begin-trial-runs-in-july/
Blue Bell To Begin Trial Runs In July
July 8, 2015 1:34 PM
FORT WORTH (KRLD/CBSDFW.COM) – After a nearly four month absence from store shelves, Blue Bell ice cream could make a comeback before summer’s end.
The company will begin trial runs at its Sylacauga, Alabama plant during the week of July 20, as part of its plan to get the ice cream back in grocer’s freezers.
The costs of this contamination event will be tremendous. First and foremost, are the people who contracted Listeria and their associated costs. Then the legal fees. The cost to the people who were laid off or furloughed (roughly 1,400 in each category). The company also has the cost of the recall and the lost revenues for 4 months of product. Then there will be costs associated with resuming production....costs of improvements to the operation, retraining of employees, conducting trial runs, etc. Getting back into the market place will not be cheap....regaining freezer shelf-space (you don't think those retailers let that space go empty for 4 months), restarting a distribution system, etc. And then regaining sales....the loyal will be back, but many other will be hesitant or leery, while others have moved on to other brands....the lost customer is very difficult, if not impossible to recover.
And what if they find it again....certainly this has been the case in a number of facility-related contamination events......
CBS DFW
http://dfw.cbslocal.com/2015/07/08/blue-bell-to-begin-trial-runs-in-july/
Blue Bell To Begin Trial Runs In July
July 8, 2015 1:34 PM
FORT WORTH (KRLD/CBSDFW.COM) – After a nearly four month absence from store shelves, Blue Bell ice cream could make a comeback before summer’s end.
The company will begin trial runs at its Sylacauga, Alabama plant during the week of July 20, as part of its plan to get the ice cream back in grocer’s freezers.
Wednesday, February 11, 2015
Study - Bacterial Diversity in a City Environment - No Reason to Fear
A recent study looked at the human and bacterial diversity that exists on NYC subways. The study, Geospatial Resolution of Human and Bacterial Diversity with City-Scale Metagenomics, (Afshinnekoo, et al. 2015) finds that the subway is teaming with a great diversity of microbes and the cells of humans. Pathogenic organisms are found, but with no cases of reported illnesses in this area, it is surmised that this is just part of the normal urban microbial environment. Bacterial species associated with the skin are present in higher proportions compared to bacterial species associated with the intestinal tract (poop bacteria).
Of course to read the headlines (NY Times, New Republic), it can be unsettling to some that so much 'contamination' present....whether it is human cells, bacteria, or viruses. Heck, there are bacterial species that have not yet been determined.
But as this is life on earth. It is not sterile. We coexist with a lot of microorganisms. For the most part, they are under control. However, there are certain instances, when our immune system is off or we encounter a large dose of a given microorganism (such as when we temperature abuse our food), we get sick. But encountering a diversity of microorganisms is important for our immune systems to develop. So don't worry about the myriad of microorganisms on the subway, embrace the fact that that 'what doesn't kill me, makes me stronger". And wash your hands before dinner.
A few passages from the study:
Of course to read the headlines (NY Times, New Republic), it can be unsettling to some that so much 'contamination' present....whether it is human cells, bacteria, or viruses. Heck, there are bacterial species that have not yet been determined.
But as this is life on earth. It is not sterile. We coexist with a lot of microorganisms. For the most part, they are under control. However, there are certain instances, when our immune system is off or we encounter a large dose of a given microorganism (such as when we temperature abuse our food), we get sick. But encountering a diversity of microorganisms is important for our immune systems to develop. So don't worry about the myriad of microorganisms on the subway, embrace the fact that that 'what doesn't kill me, makes me stronger". And wash your hands before dinner.
A few passages from the study:
Thursday, October 25, 2012
Problems at NECC facility that led to meningitis outbreak
This is not food related, but the issues seen at this facility that made the contaminated epidurals that led to the fungal meningitis outbreak provide lessons in product and environmental control.
· Firm shipped product before receiving sterility results (results were negative however).
· Firm didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility
· Firm didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications
· Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
In the report below, Massachusetts Governor Patrick states that over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
Not sure I want my local pharmacy making medicine, especially ones that can be injected in me. Dispensing medicine is one thing, but making it, no thanks.
We see this type of thing in food companies as well…the firm expands into a niche outside of their core competency and grow the business, but never become technically competent in that new business. They fail to spend the capital on the facility needed to meet the requirements of producing that product. Then, as more product is shipped, the inevitable production error occurs, impacting far too many.
Report airs problems at firm linked to fungal meningitis outbreak
Lisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/other/news/oct2412fungal2-jw.html
Oct 24, 2012 (CIDRAP News) – Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results.
Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.
Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.
Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17.
The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis.
In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.
NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.
According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.
In addition, authorities found that the company didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility.
The report also says NECC didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications.
Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
At the media briefing, Massachusetts governor Deval Patrick said federal officials have launched a criminal investigation into NECC's actions and he announced more steps the state and its Board of Pharmacy have taken in response to the steroid contamination, including permanently revoking NECC's operating license and those of its three principal pharmacists.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," he said.
Patrick said that, over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
The state will now require compounding pharmacies in Massachusetts to submit annual production, volume, and distribution reports to make it easier for authorities to flag operations that are acting more like manufacturers, which require federal licensing and extra scrutiny, Patrick said. He added that the state will require compounding pharmacies to report interactions with federal regulators and will form a special commission to examine best practices in other states and what changes may be needed at the federal level.
· Firm shipped product before receiving sterility results (results were negative however).
· Firm didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility
· Firm didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications
· Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
In the report below, Massachusetts Governor Patrick states that over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
Not sure I want my local pharmacy making medicine, especially ones that can be injected in me. Dispensing medicine is one thing, but making it, no thanks.
We see this type of thing in food companies as well…the firm expands into a niche outside of their core competency and grow the business, but never become technically competent in that new business. They fail to spend the capital on the facility needed to meet the requirements of producing that product. Then, as more product is shipped, the inevitable production error occurs, impacting far too many.
Report airs problems at firm linked to fungal meningitis outbreak
Lisa Schnirring Staff Writer
http://www.cidrap.umn.edu/cidrap/content/other/news/oct2412fungal2-jw.html
Oct 24, 2012 (CIDRAP News) – Massachusetts officials yesterday said New England Compounding Center (NECC), the firm linked to a multistate fungal meningitis outbreak, sent shipments from two of the recalled lots before it received sterility testing results.
Investigators also found black particulate matter in several unopened vials of the recalled methylprednisolone acetate, which was used in epidural injections for back pain and injections for peripheral joint problems, according to a report of preliminary investigation findings.
Federal officials have said that as many as 14,000 patients could have been exposed to the recalled injections.
Nine more infections have been reported in the outbreak, raising the number of infections to 317, the US Centers for Disease Control and Prevention (CDC) said today in its latest update. One more death was reported, putting that total at 24, and the number of affected states held steady at 17.
The CDC reported one more joint infection linked to the contaminated steroids, raising that number to five, and it said 54 cases have now been confirmed with lab tests. So far all but two of the infections involve Exserohilum rostratum, a type of black mold that hadn't previously been known to cause meningitis.
In a press conference with reporters yesterday, Madeleine Biondolillo, MD, who directs the Massachusetts Department of Public Health's Bureau of Health Care Safety and Quality, said the investigation began on Sep 25 and involves collaboration with their colleagues at the US Food and Drug Administration (FDA) since Oct 1. She said the investigation is ongoing and that authorities have obtained evidence, reviewed NECC's standard operating procedures, probed the company's records, and interviewed its employees.
NECC didn't label the medications for specific patients, a violation of Massachusetts licensing regulations for compounding pharmacies, Biondolillo said.
According to the Massachusetts Department of Public Health (MDPH) investigation report, NECC's sterility tests on the shipments sent before results came in didn't show contamination. However, investigators said they were still exploring the adequacy of NECC's testing methods.
In addition, authorities found that the company didn't follow established standards for autoclaving and didn't keep products in the autoclave for the minimum 20 minutes needed to ensure sterility.
The report also says NECC didn't thoroughly clean powder hoods used to protect pharmacists while they prepare compounded substances. Investigators observed residual powder within the hood, which could lead to contamination of medications.
Mats designed to trap dirt and other contaminants were visibly soiled, and a leaking boiler next to the clean room caused water to pool around it and adjacent walls, creating conditions that could support contaminant growth, according to the findings.
At the media briefing, Massachusetts governor Deval Patrick said federal officials have launched a criminal investigation into NECC's actions and he announced more steps the state and its Board of Pharmacy have taken in response to the steroid contamination, including permanently revoking NECC's operating license and those of its three principal pharmacists.
"Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again," he said.
Patrick said that, over the years, some pharmacies have evolved from neighborhood drug stores to large-scale manufacturers that sell products across state lines, and that regulations in Massachusetts and at the federal level have not kept pace with the changes. He said that he had directed the pharmacy board to start making unannounced inspections of compounding pharmacies that make sterile injectable medications and strengthen penalties for pharmacies that don't comply with rules.
The state will now require compounding pharmacies in Massachusetts to submit annual production, volume, and distribution reports to make it easier for authorities to flag operations that are acting more like manufacturers, which require federal licensing and extra scrutiny, Patrick said. He added that the state will require compounding pharmacies to report interactions with federal regulators and will form a special commission to examine best practices in other states and what changes may be needed at the federal level.
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