Michigan Establishment Recalls Frozen Meatloaf Due To Complaint of Metal Bits

Ada Valley Gourmet Foods, Inc., an Ada, Mich. establishment, is recalling approximately 3,490 pounds of raw ground beef meatloaf products that may be contaminated with extraneous materials, specifically broken metal bits.  The problem was discovered on July 11, 2019, when a customer notified the plant of the problem.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-073-2019-release
Ada Valley Gourmet Foods, Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
Class I Recall 
073-2019 
Health Risk:High 
Jul 13, 2019 

Over 100 with E. coli after Visiting Minnesota Lake on 4th

Between 120 and 150 people have become infected with pathogenic E. coli after boating on Lake Minnetonka in Minnesota. Environmental factors are the most likely source.

Star Tribune
http://www.startribune.com/at-least-140-report-sickness-after-lake-minnetonka-boating-on-july-4th/512542682/
Nearly 120 report sickness after Lake Minnetonka boating on July 4th
Five beaches in the metro area remain closed due to high bacteria
counts.
By Katy Read (http://www.startribune.com/katyread/
131074183/) Star Tribune
JULY 11, 2019 — 5:07AM

Woman Charged After Video of Her Child Licking a Tongue Depressor and Placing it Back

A woman was charged with tampering, a felony, after she posted a video of her 10 year old daughter licking a tongue depressor in the doctor's office examination room and then returning it to the same jar.  This comes after last week's ice cream tampering issues when on two different occasions, stupid people opened, licked, and replaced cartons of ice cream.

PennLive
https://www.pennlive.com/nation-world/2019/07/woman-charged-after-recording-daughter-licking-tongue-depressor-in-doctors-office-and-putting-it-back.html
Woman charged after recording daughter licking tongue depressor in doctor’s office and putting it back
7/12/19   8:17 AM

This Week in Mislabeled Product for Week Ending July 13, 2019

Consumer Allergic Reaction Triggers Recall of  Meal Bars -  PROBAR LLC of Salt Lake City, UT has initiated a voluntary recall of select flavors and lots of Meal® bars, including Chocolate Coconut, Peanut Butter Chocolate Chip, Original Trail Mix, Wholeberry Blast and Superfood Slam due to the possible presence of undeclared milk and soy allergens. PROBAR learned of the issue after receiving a complaint of an allergic reaction in a consumer after eating a PROBAR: MEAL Peanut Butter Chocolate Chip bar. Our investigation determined that an ingredient potentially contained milk and soy. To date, PROBAR has received this one report of illness.

Someone Missed that Worcestershire Sauce Contains Fish (anchovies) - .Baumer Foods, Inc. of Metairie, LA is recalling 10 oz PICS Soy Sauce, because it may contain undeclared fish   The recall was initiated after it was discovered that product was labeled as Soy Sauce without the known fish allergen but the bottle actually contained Worcestershire sauce. Worcestershire Sauce has the known allergen fish. Subsequent investigation indicates the problem was caused by a temporary oversight during the packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/probar-llc-issues-allergy-alert-undeclared-milk-and-soy-select-flavors-meal-r-bars
PROBAR LLC Issues Allergy Alert on Undeclared Milk and Soy in Select Flavors of Meal ® Bars
Summary
Company Announcement Date:  July 11, 2019
FDA Publish Date:  July 11, 2019
Product Type:  Food & Beverages  Meal Replacements
Reason for Announcement:Undeclared Milk and Soy
Company Name:PROBAR
Brand Name:PROBAR
Product Description:Multiple flavors of Meal Bars

Hamburger Buns and Hot Dog Buns Recalled Due to Potential for Hard Plastic

Flowers Foods, Inc. is voluntarily recalling hamburger and hot dog buns and other bakery products due to the potential presence of small pieces of hard plastic that may have been introduced during production.  The company initiated the recall following the discovery of small pieces of hard plastic in production equipment.No related injuries or illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flowers-foods-issues-voluntary-recall-hamburger-and-hot-dog-buns-and-other-bakery-foods-due-plastic
Flowers Foods Issues Voluntary Recall of Hamburger and Hot Dog Buns and Other Bakery Foods Due to Plastic Pieces Found in Products
Summary
Company Announcement Date: July 09, 2019
FDA Publish Date: July 10, 2019
Product Type:Food & Beverages  Bakery Product/Mix
Reason for Announcement: Potential Presence of Small Pieces of Hard Plastic
Company Name:Flowers Foods, Inc.
Brand Name: Multiple brands
Product Description:  Hamburger and Hot Dog Buns

Meat and Gravy Product Recalled After Complaint of Clear Pliable Plastic

Fairmont Foods, Inc. of Fairmont, Minn. is recalling approximately 35,145 pounds of ready-to-eat pork and beef gravy products that may be contaminated with extraneous materials, specifically clear pliable plastic (ingredient packaging material??).  The firm contacted FSIS after they received a report that a consumer found a piece of the soft pliable plastic in the product.  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-072-2019-release
Fairmont Foods, Inc. Recalls Ready-To-Eat Pork and Beef Gravy Products Due to Possible Foreign Matter Contamination
Class II Recall 
072-2019 
Health Risk: Low 
Jul 9, 2019

Restaurant in FL Linked to Cyclospora Outbreak

A restaurant in Florida has been linked to a Cyclospora outbreak.  The source has yet to be identified, but in many cases related to this parasite, it tends to be produce which was watered or washed with water contaminated with the parasite.

Cyclospora is a single cell parasite where humans are the only definitive host.  From the CDC:

People become infected with Cyclospora by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) Cyclospora oocysts in the feces. The oocysts are thought to require at least 1–2 weeks in favorable environmental conditions to sporulate and become infective. Therefore, direct person-to-person transmission is unlikely, as is transmission via ingestion of newly contaminated food or water.

 In the United States, foodborne outbreaks of cyclosporiasis have been linked to various types of imported fresh produce, such as raspberries, basil, snow peas, mesclun lettuce, and cilantro; no commercially frozen or canned produce has been implicated to date.

So while many may blame the restaurant, that restaurant was unlikely to have had much impact on removing the parasite if already on the produce.   And this is the challenge with Cyclospora.  Last month, a panel was put together to investigate how this parasite can be controlled.  While some preventive measures were discussed, no specific source was identified.

https://www.news4jax.com/news/local/jacksonville/attorneys-2-dozen-sick-after-food-poisoning-at-popular-restaurant
Attorneys: About 2 dozen sick after food poisoning at popular restaurant
Group claims to have contracted parasite from Cooper's Hawk Winery & Restaurant
By Vic Micolucci - I-TEAM reporter, anchor
Posted: 3:10 PM, July 09, 2019
Updated: 12:41 PM, July 10, 2019

FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

FDA Warning Letter Issued to Pet Food Company for Inadequate Food Safety Plan

A pet food facility based in Tupelo MS (birthplace of Elvis) received a Warning Letter from FDA regarding making product with high Vitamin D levels.   In a nutshell, their Food Safety Plan did not sufficiently consider that their supplier could provide product with a different Vitamin D content than what their formulation called for, thus they ended up making product with excessive Vitamin D, which is harmful to pets.  In this case, they used an ingredient with over 60X the Vitamin D level

A few important points here: 1) When requiring COAs, one needs to be specific to the hazard they are looking for, and the level.  Too many people collect COAs just to collect them.  2) If one asks for a COA, then it must be reviewed, and in many cases verified.  3) All incoming materials should be checked for ingredient / raw material numbers to make sure they match.
Care must be taken when writing the Preventive Control Plan because it will be used to evaluate the facility.  Unfortunately, emphasis provided in the Animal Feed courses is not as good as in the Human Food courses in that it allows many ingredients to be lumped together.

Specifically, you identified vitamin and mineral toxicity and deficiency as a hazard requiring a preventive control in your food safety plan. However, as evidenced by the toxic levels of vitamin D found in some of your dog foods, you failed to implement adequate preventive controls to ensure your inclusion of vitamin D did not result in a nutrient toxicity or deficiency.

Your hazard analysis determined that a preventive control was not necessary at ingredient receiving for “wrong levels” of vitamins in ingredients due to your “internal programs.” .........

Your “internal programs” consist of SOP number (b)(4) and SOP number (b)(4).” With regard to micro ingredients, SOP (b)(4) states that “all bagged raw materials will provide a Certificate of Analysis (COA), which will be maintained in the ingredient purchasing office.” (b)(4) says that “it is the policy of Sunshine Mills that all incoming shipments of raw materials used in our products, including bulk grains, bulk protein and other meals, bulk fats and tallows, salt, packaged vitamin and mineral supplements, color additives, and other ingredients will be examined at the time of receipt to assure that they are of good quality and meet product specifications. This examination will consist of a visual inspection for identity and gross visible defects, a test for moisture content as may be indicated, and sampling for assay of protein, fiber, vitamin and mineral levels or other purchase specifications, and also to check for contaminants.” It is also your policy that “vendors, from time to time, provide a COA for such things as vitamin and mineral content when this is part of the puce-chase [sic] specifications.”

However, these SOPs did not ensure that vitamin D levels in incoming ingredients met established ingredient specifications. For example, the vitamin D levels were not analyzed at a laboratory facility on a routine basis to ensure that the vitamin D met your firm’s pre-set formulation. You did not question any difference in appearance of the packaging or the ingredient. In addition, your firm did not obtain Certificates of Analysis (COA) upon receipt of each shipment of vitamin D. Furthermore, there is no indication of who is responsible for performing these actions listed in the SOPs or verifying that they have been performed or what steps are to be taken if an incoming ingredient does not meet specifications.

Your “batching/mixing” preventive control includes no measures that would prevent the use of an ingredient that is the wrong concentration.

Consequently, you used five shipments of an ingredient that you were unaware contained a higher concentration of vitamin D (500,00 IU/g) instead of the vitamin D with a lower concentration (7,500 IU/g) consistent with your firm’s formulation.

2. ......Your firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 507.33(a)(1).

Specifically, your firm manufactures cat food that includes thermal processing (extrusion) as a manufacturing step. Your hazard analysis did not identify inadequate thiamine in extruded dry cat food as a known or reasonably foreseeable hazard.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-576411-06252019
WARNING LETTER
Sunshine Mills Inc 
MARCS-CMS 576411 — Jun 25, 2019