North Bay Produce, Inc. of Traverse City, Michigan is voluntarily recalling 2,297 cases and 2 bulk bins of fresh apples due to the potential to be contaminated with Listeria monocytogenes. The recall was initiated as a result of a finished product test that indicated the presence of the organism. Upon notification, [the company] immediately ceased the production and distribution product from the identified facility and continue [the] investigation as to what caused the issue, in cooperation with FDA.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/north-bay-produce-voluntarily-recalls-fresh-apples-because-possible-health-risk
North Bay Produce Voluntarily Recalls Fresh Apples Because of Possible Health Risk
Company Announcement
Summary
Company Announcement Date: October 25, 2019
FDA Publish Date:October 28, 2019 .
Product Type:Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name:North Bay Produce, Inc.
Brand Name: Great Lakes, more
Product Description: Fresh apples varieties:
Wednesday, October 30, 2019
Friday, October 25, 2019
This Week in Mislabeled Product for Week Ending 10/26/19
Dried Fruit with Sulfites - Shivam Distributors of Longwood, FL is recalling its 7 ounce and 14 ounce packages of PARIVAR brand Dry Dates with batch # 125/BIBT because they contain high sulfite content, The recall was the result of a surveillance testing done by FL Dept of Agriculture that revealed high sulfite level in the 7 ounce packages of “Dry Dates” with batch # 125/BIBT.
Labels Missing Milk and Soy - MawMaw’s Chicken Pies, a Kernersville, N.C. establishment, is recalling an undetermined amount of chicken pie and meatloaf products due to misbranding and undeclared allergens - the products contain milk and soy, known allergens, which are not declared on the product label. The problem was discovered by FSIS inspectors during routine label verification activities.
Labels Missing Milk and Soy - MawMaw’s Chicken Pies, a Kernersville, N.C. establishment, is recalling an undetermined amount of chicken pie and meatloaf products due to misbranding and undeclared allergens - the products contain milk and soy, known allergens, which are not declared on the product label. The problem was discovered by FSIS inspectors during routine label verification activities.
Canada - E. coli Associated Recall of Raw Meat Products Expanded
The Canadian Food Inspection Agency (CFIA) has announced an increase in the amount of beef product being recalled by Ryding-Regency Meat Packers Ltd. and St. Ann's Foods Inc./Ryding-Regency Meat Packers Ltd. due to potential E. coli O157:H7. Some of this product was shipped into the US.
http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1
Food safety investigation: Various beef and veal products may contain E. coli O157:H7
The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation on E. coli O157:H7 in various beef and veal products sold by Ryding-Regency Meat Packers Ltd. (Establishment 99) and St. Ann's Foods Inc./Ryding-Regency Meat Packers Ltd. (Establishment 639). Should there be a recall of additional products, CFIA will notify the public through additional Food Recall Warnings.
To date, there have been no reported illnesses associated with the consumption of these products.
The complete list can be found here.
http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1
http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1
Food safety investigation: Various beef and veal products may contain E. coli O157:H7
The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation on E. coli O157:H7 in various beef and veal products sold by Ryding-Regency Meat Packers Ltd. (Establishment 99) and St. Ann's Foods Inc./Ryding-Regency Meat Packers Ltd. (Establishment 639). Should there be a recall of additional products, CFIA will notify the public through additional Food Recall Warnings.
To date, there have been no reported illnesses associated with the consumption of these products.
The complete list can be found here.
http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1
Thursday, October 24, 2019
FDA Warning Letter - Manufacturer of Vitamin Premix Ingredient with Elevated Vitamin D Levels
FDA issued a warning letter to an ingredient manufacturer responsible for recalls if pet food associated with high Vitamin D levels in finished product. The ingredient made was a vitamin premix and the levels were 3900% higher on the particular lot, and that high level than carried over to another lot that had levels 307% more.
It is interesting in that the company stated in the hazard analysis that although Vitamin D was identified as a hazard in the formulation, it would be controlled through prerequisite programs. This of course failed with high Vitamin D levels getting into their premix and thus their customer's finished product and then finally that product impacting dogs.
Another interesting point to note is that the responses provided by the company to FDA were viewed as inadequate. Although the company stated that they took corrective action after the incident, including making hazardous ingredient addition a preventive control, they did not provide FDA sufficient documentation for the control of their process. The FDA response states, the company "did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm."
Warning Letter
It is interesting in that the company stated in the hazard analysis that although Vitamin D was identified as a hazard in the formulation, it would be controlled through prerequisite programs. This of course failed with high Vitamin D levels getting into their premix and thus their customer's finished product and then finally that product impacting dogs.
Another interesting point to note is that the responses provided by the company to FDA were viewed as inadequate. Although the company stated that they took corrective action after the incident, including making hazardous ingredient addition a preventive control, they did not provide FDA sufficient documentation for the control of their process. The FDA response states, the company "did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm."
Warning Letter
DSM Nutritional Products, LLC
MARCS-CMS 578300 — October 11, 2019
MARCS-CMS 578300 — October 11, 2019
FDA Warning Letter - Another Bakery Unaware of the Need to Comply with Preventive Controls Regulation
FDA issued a Warning Letter to a bakery / central kitchen in Alabama. The bakery had no Preventive Control Plan, and with that, had no controls for hazards one would expect in that type of operation. Additionally, they had GMP issues, primarily filth insects, facility issues, and sanitation issues. Finally, there were labeling issues including not properly identifying allergens.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pollmans-bake-shops-inc-586422-10092019
WARNING LETTER
Pollman's Bake Shops, Inc.
MARCS-CMS 586422 — October 09, 2019
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pollmans-bake-shops-inc-586422-10092019
WARNING LETTER
Pollman's Bake Shops, Inc.
MARCS-CMS 586422 — October 09, 2019
Florida Establishment Recalls Raw Beef Product After Positive E. coli Test Results
Pride of Florida, a Raiford, Fla. establishment, is recalling approximately 64,797 pounds of raw beef products that may be contaminated with E. coli O157:H7. The raw ground beef items were produced on various dates from Sept. 23, 2019 to Oct. 10, 2019. "The problem was discovered when the firm was notified by their third-party laboratory that a sample was positive for E. coli O157:H7, but the products associated with the sample had already been shipped into commerce. There have been no confirmed reports of adverse reactions due to consumption of these products.
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-101-2019-release
Pride of Florida Recalls Beef Products due to Possible E. Coli O157:H7 Contamination
Class I Recall
101-2019
Health Risk: High
Oct 18, 2019
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-101-2019-release
Pride of Florida Recalls Beef Products due to Possible E. Coli O157:H7 Contamination
Class I Recall
101-2019
Health Risk: High
Oct 18, 2019
Egg Rolls Recalled for Being Produced Under Unsanitary Conditions, Recall Then Expanded
A St. Louis establishment is recalling 126,000 lbs of egg roll products for being produced under unsanitary conditions. The problem was discovered while FSIS was conducting routine food inspection activities. Product was shipped to institutional locations in Georgia and Missouri.
On 10/25, a week after initial recall, the recall was expanded from 118,00 to 126,000 lbs.
On 10/25, a week after initial recall, the recall was expanded from 118,00 to 126,000 lbs.
Additional information was difficult to find on the types of conditions inspectors found. In fact, it was difficult to find any information on the company outside of an address in St. Louis that was in the back of some older building complex with no signage posted.
Makes you wonder how one selects this company to supply product.
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-100-2019-release
T & R Enterprise USA Inc. Recalls Meat and Poultry Products Due to Insanitary Conditions
Class I Recall
100-2019
Health Risk: High
Oct 18, 2019
Makes you wonder how one selects this company to supply product.
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-100-2019-release
T & R Enterprise USA Inc. Recalls Meat and Poultry Products Due to Insanitary Conditions
Class I Recall
100-2019
Health Risk: High
Oct 18, 2019
Monday, October 21, 2019
Sausage Patties Recalled Due to Potential Salmonella Contamination
George’s Prepared Foods, a Caryville, Tenn. establishment, is recalling approximately 6,444 pounds of ready-to-eat (RTE) pork sausage patty and turkey sausage patty products that may be contaminated with Salmonella. The problem was discovered when the firm notified FSIS that the firm’s third-party cold storage facility had inadvertently shipped the ready-to-eat products to commerce.
So one could guess that the product had been placed on hold and then was accidently shipped?
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-102-2019-release
George's Prepared Foods Recalls Ready-To-Eat Pork and Turkey Products due to Possible Salmonella Contamination
Class I Recall
102-2019
Health Risk: High
Oct 18, 2019
So one could guess that the product had been placed on hold and then was accidently shipped?
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-102-2019-release
George's Prepared Foods Recalls Ready-To-Eat Pork and Turkey Products due to Possible Salmonella Contamination
Class I Recall
102-2019
Health Risk: High
Oct 18, 2019
Thursday, October 17, 2019
Imported Meat from Canada Recalled Due to Potential Pathogenic E. coli Contamination
The USDA FSIS issued a public health alert for raw non-intact beef products derived from imported beef from Ontario, Canada that has been recalled by Ryding-Regency Meat Packers, Ltd. because it may be contaminated with E. coli O157:H7.
"The Canadian Food Inspection Agency is conducting a food safety investigation and determined that certain products produced by the company may be contaminated. While Canada is the recalling authority, FSIS is amplifying the recall through this public health alert."
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2019/pha-101619-01
FSIS Issues Public Health Alert for Beef Products due to Possible E. coli O157:H7 Contamination
"The Canadian Food Inspection Agency is conducting a food safety investigation and determined that certain products produced by the company may be contaminated. While Canada is the recalling authority, FSIS is amplifying the recall through this public health alert."
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2019/pha-101619-01
FSIS Issues Public Health Alert for Beef Products due to Possible E. coli O157:H7 Contamination
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