Blue Bell Ice Cream is recalling one specific lot of half gallon Butter Crunch Ice Cream produced on a specific line on August 26, 2019 in its Sylacauga, AL plant after being notified by a consumer of the presence of a piece of a plastic tool in a half gallon of Butter Crunch Ice Cream. "The company investigation revealed the broken tool was inadvertently incorporated into the production process in a small amount of product."
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-bell-ice-cream-recalls-select-lot-butter-crunch-half-gallons-possible-foreign-object
Blue Bell Ice Cream Recalls a Select Lot of Butter Crunch Half Gallons for Possible Foreign Object
Summary
Company Announcement Date: October 08, 2019
FDA Publish Date: October 09, 2019
Product Type: Food & Beverages Ice Cream/Frozen Dairy
Reason for Announcement: Foreign object
Company Name: Blue Bell Ice Cream
Brand Name: Blue Bell
Product Description: Butter Crunch Ice Cream
Friday, October 11, 2019
Wednesday, October 9, 2019
CDC Report: Tuberculosis in Deer Can Be Transmitted to Hunters During Field Dressing
A CDC report reviews a case of pulmonary tuberculosis in an elderly man that was linked to wild deer. It serves as a reminder to deer hunters to take this into consideration as they field dress their deer.
Penn State Extension has a guide for safely field dressing your deer.
Penn Live
https://www.pennlive.com/life/2019/09/deer-can-transmit-tuberculosis-to-hunters-warns-cdc.html
Deer can transmit tuberculosis to hunters, warns CDC
Posted Sep 26, 2019
By Marcus Schneck | mschneck@pennlive.com
A 77-year-old Michigan hunter apparently contracted tuberculosis from an infected wild deer that he killed and field-dressed, providing further evidence that deer with TB can transmit the disease to humans, according to the Centers for Disease Control and Prevention.
Penn Live
https://www.pennlive.com/life/2019/09/deer-can-transmit-tuberculosis-to-hunters-warns-cdc.html
Deer can transmit tuberculosis to hunters, warns CDC
Posted Sep 26, 2019
By Marcus Schneck | mschneck@pennlive.com
A 77-year-old Michigan hunter apparently contracted tuberculosis from an infected wild deer that he killed and field-dressed, providing further evidence that deer with TB can transmit the disease to humans, according to the Centers for Disease Control and Prevention.
RTE Chicken Processor Reissues Recall to Retail Delis for Product Potentially Tainted with Listeria
Tip Top Poultry reissued their recall of RTE frozen cooked, diced or shredded chicken products to notify that retailers may have purchased this product and used it for chicken salad sold in various store delis and foodservice operations. Stores include Food Lion, IGA, Harris Teeter, Piggly Wiggly, Giant, Aldi, Kroger, as well as others The initial recall was issued on September 28, 2019.
Another sandwich processor, Jumbo Foods Inc. of Mukilteo, WA issued a recall of its Tuscan Sun (TS) brand chicken salad sandwiches. Jumbo Foods Inc began shipping these frozen or refrigerated sandwiches products between March 11, 2019 and September 27, 2019. Frozen sandwiches have no sell by or use by date printed on packages and have 8 months shelf life. (mmm...what's more tasty than an 8 month old frozen chicken salad sandwich).
The issue began in August when the Canadian Food Inspection Agency investigated an outbreak in Canada where 7 people became infected. The CFIA then linked the outbreak to this GA establishment.
In terms of supplier control of a RTE item which would be considered high risk, some state that it should be sufficient for control that a supplier is operating under USDA inspected and that the product is stamped as such. This is a great example why that in of itself may not be enough.
Another sandwich processor, Jumbo Foods Inc. of Mukilteo, WA issued a recall of its Tuscan Sun (TS) brand chicken salad sandwiches. Jumbo Foods Inc began shipping these frozen or refrigerated sandwiches products between March 11, 2019 and September 27, 2019. Frozen sandwiches have no sell by or use by date printed on packages and have 8 months shelf life. (mmm...what's more tasty than an 8 month old frozen chicken salad sandwich).
The issue began in August when the Canadian Food Inspection Agency investigated an outbreak in Canada where 7 people became infected. The CFIA then linked the outbreak to this GA establishment.
In terms of supplier control of a RTE item which would be considered high risk, some state that it should be sufficient for control that a supplier is operating under USDA inspected and that the product is stamped as such. This is a great example why that in of itself may not be enough.
Next step will be to determine whether this product sold in the US has resulted in any Listeria cases.
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-094-2019-release
Tip Top Poultry, Inc. Recalls Ready-To-Eat Poultry Products Due to Possible Listeria Contamination
Class I Recall
094-2019
Health Risk: High
Sep 28, 2019
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-094-2019-release
Tip Top Poultry, Inc. Recalls Ready-To-Eat Poultry Products Due to Possible Listeria Contamination
Class I Recall
094-2019
Health Risk: High
Sep 28, 2019
FDA Warning Letter - RTE Salad Company
FDA issued a warning letter ready-to-eat RTE prepared foods manufacturing facility that produced RTE salads. There are issues with the Preventive Control Plan as well as GMP issues. One of the interesting items regarding their plan was that they were not following it. Item number 3 below points out how many people write up a plan, and in that plan, they overstate what they do.
1) Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections". "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."
Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"
2) FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "
3) The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list. Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad. Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"
4) GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room. This area was observed to be a high employee and equipment traffic area. These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.
5) GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019
1) Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections". "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."
Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"
2) FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "
3) The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list. Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad. Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"
4) GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room. This area was observed to be a high employee and equipment traffic area. These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.
5) GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019
Tuesday, October 8, 2019
Company Recalls Ham Sandwiches Due to Listeria Contamination.
Lipari Foods has issued a voluntary recall of Premo Ham & Cheese Wedge Sandwiches and Fresh Grab Ham & Cheese Wedge Sandwiches due to potential contamination of Listeria monocytogenes. Lipari Foods is expanding its recall from 10/2/19 to include one lot of Ham & Cheese Wedge Sandwiches produced by JLM Manufacturing due to potential contamination of Listeria monocytogenes. The potential for contamination of this particular lot was brought to our attention during an FDA investigation of the previous recall.
The initial issue was the chicken used for chicken salad. One could guess that during the FDA recall, they found that the ham sandwich product was packed in same area where the recalled chicken was handled and there was no complete clean step between handling the recalled product and the ham product. Because of that, there would be the risk that the ham sandwich product became contaminated.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-recall-ham-cheese-wedge-sandwiches-due-potential-contamination-listeria
Lipari Foods Issues Recall of Ham & Cheese Wedge Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: October 07, 2019
FDA Publish Date: October 08, 2019
Product Type: Food & Beverages Prepared Food
Reason for Announcement: Potential contamination with Listeria monocytogenes
Company Name: Lipari Foods
Brand Name: Premo and Fresh Grab
Product Description: Ham and cheese wedge sandwiches
The initial issue was the chicken used for chicken salad. One could guess that during the FDA recall, they found that the ham sandwich product was packed in same area where the recalled chicken was handled and there was no complete clean step between handling the recalled product and the ham product. Because of that, there would be the risk that the ham sandwich product became contaminated.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-recall-ham-cheese-wedge-sandwiches-due-potential-contamination-listeria
Lipari Foods Issues Recall of Ham & Cheese Wedge Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: October 07, 2019
FDA Publish Date: October 08, 2019
Product Type: Food & Beverages Prepared Food
Reason for Announcement: Potential contamination with Listeria monocytogenes
Company Name: Lipari Foods
Brand Name: Premo and Fresh Grab
Product Description: Ham and cheese wedge sandwiches
Friday, October 4, 2019
This Week in Allergen Related Recalls for Week Ending October 5, 2019
Peanuts in Peppermint Ice Cream - Ample Hills Manufacturing of Brooklyn, New York is recalling all half pints of Peppermint Pattie Ice Cream (lot code 19169, all time stamps with Best by Date 6/18/20) (80z) (236ml) because they may contain undeclared peanut. The recall was initiated after it was discovered that Peppermint Pattie ice cream (lot code 19169) containing peanut allergen was inadvertently discovered in a tub packaging and as a preventative caution, we are recalling all products made that day with that specific lot code as the ingredient statement on this ice cream does not reveal the presence of peanut allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in allergen control processes.
Label Missing Sulfites - Super World Trading Inc. of Brooklyn, New York is recalling 10 cases of 12 oz Dried Date with incorrect label as shown below, because it may contain undeclared sulfites. The recall was initiated after it was discovered that product containing sulfite was distributed in packaging that did not reveal the presence of sulfite. Subsequent investigation indicates the problem was caused by a mislabeled in the packaging.
Undeclared Milk and Egg - RONG SHING NY Trading Inc. of Brooklyn, NY, is recalling its 6-ounce packages of GLAM DAY NOUGAT CANDY because they may contain undeclared milk and egg allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk and eggs in the product.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ample-hills-manufacturing-llc-issues-allergy-alert-undeclared-peanut-peppermint-pattie-ice-cream
Ample Hills Manufacturing, LLC Issues Allergy Alert on Undeclared Peanut in Peppermint Pattie Ice Cream
Label Missing Sulfites - Super World Trading Inc. of Brooklyn, New York is recalling 10 cases of 12 oz Dried Date with incorrect label as shown below, because it may contain undeclared sulfites. The recall was initiated after it was discovered that product containing sulfite was distributed in packaging that did not reveal the presence of sulfite. Subsequent investigation indicates the problem was caused by a mislabeled in the packaging.
Undeclared Milk and Egg - RONG SHING NY Trading Inc. of Brooklyn, NY, is recalling its 6-ounce packages of GLAM DAY NOUGAT CANDY because they may contain undeclared milk and egg allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk and eggs in the product.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ample-hills-manufacturing-llc-issues-allergy-alert-undeclared-peanut-peppermint-pattie-ice-cream
Ample Hills Manufacturing, LLC Issues Allergy Alert on Undeclared Peanut in Peppermint Pattie Ice Cream
FDA Releases New Draft Guidance Chapter - Recall Plan
FDA released a new guidance document on 'recalls' as part of a series of chapters on the FSMA regulation. This new document titled - Chapter 14: Recall Plan provides FDA's current thinking on what you need to do when writing your company's recall plan.
That document can be found here - https://www.fda.gov/media/131287/download
It would be a good idea to review this document to ensure your current plan reflects what FDA states for each of the elements.
That document can be found here - https://www.fda.gov/media/131287/download
It would be a good idea to review this document to ensure your current plan reflects what FDA states for each of the elements.
NIH Report - 40% Household Bleach Deactivates CWD Prions
A 5-minute soak in a 40% solution of household bleach (6% sodium hypochlorite) decontaminated stainless steel wires coated with chronic wasting disease (CWD) prions, according to a new study by National Institutes of Health scientists. The scientists used the wires to model knives and saws that hunters and meat processors use when handling deer, elk and moose – all of which are susceptible to CWD.
All bleach concentrations tested are based on undiluted Purebright brand bleach considered as 100%, which contains 6% sodium hypochlorite. So a 40% solution was 20,000 ppm.
Link to study - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223659
https://www.nih.gov/news-events/news-releases/household-bleach-inactivates-chronic-wasting-disease-prions
Household Bleach Inactivates Chronic Wasting Disease Prions
Strategy Appears Feasible for Decontaminating Hunting, Meat Processing Equipment
All bleach concentrations tested are based on undiluted Purebright brand bleach considered as 100%, which contains 6% sodium hypochlorite. So a 40% solution was 20,000 ppm.
Link to study - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223659
https://www.nih.gov/news-events/news-releases/household-bleach-inactivates-chronic-wasting-disease-prions
Household Bleach Inactivates Chronic Wasting Disease Prions
Strategy Appears Feasible for Decontaminating Hunting, Meat Processing Equipment
Indiana Company Recalls RTE Pork Product After FSIS Samples Test Positive for LM
Fisher Packing Company, a Redkey, Ind. establishment, is recalling approximately 744 pounds of ready-to-eat (RTE) pork products that may be adulterated with Listeria monocytogenes. The problem was discovered when the firm notified FSIS that a sample of product produced by Fisher Packing Company confirmed positive for the presence of Listeria monocytogenes.
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-095-2019-release
Fisher Packing Company Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
Class I Recall
095-2019
Health Risk: High
Sep 28, 2019
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-095-2019-release
Fisher Packing Company Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
Class I Recall
095-2019
Health Risk: High
Sep 28, 2019
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