Closure of Local Pizza Shop Gains Media Attention

Canyon Pizza has been a State College staple for late night pizza since 2001. Not necessary an award winning pizza, but with its large pies and cheap price, it have endured the ever changing restaurant scene in this college town. After an inspection by the local health authority this week, however, it received a lot of press, although not the good kind.

The inspection noted 13 violations.  None by itself that would store-closing, but in total, it paints the picture of a dirty operation, one that is definite need of a good scrubbing and repair.  How did it get to this point?  Didn't management look closely and think that things are not as they should be?  Why do some have to wait until an inspection in order to do the necessary work?  And now, to have the brand damaged for all to see.

PDA website for results of restaurant inspections
https://www.pafoodsafety.pa.gov/Web/Inspection/PublicInspectionSearch.aspx

4 - 301.14 Explain Code Submit
Inspector Comments
--Hood system is not adequate to remove heat and/or grease, as evidenced by condensate and/or grease collecting on the walls, ceilings, and fixtures. Hood is in need of a professional cleaning as required by the Centre Region Property Maintenance Code.

Ending the Thanksgiving Meal Controversies

Thanksgiving.   A time to gather with family and friends.  A time to feast.   A time to time to argue….umm….converse about important stuff ...like stuffing. Indeed, there are some age-old controversies surrounding the Thanksgiving meal.  Questions such as.....Is it stuffing or is it dressing? ......White meat vs dark meat? ......What is the best temperature for cooking the turkey?

To help foster a harmonious atmosphere during your holiday gathering, we will provide you with some next-level input for resolving these questions. We have assembled a Blue Ribbon Panel….Yes, I know what you are thinking….really, a Blue Ribbon Panel? Yes, a Blue Ribbon Panel indeed and that means this s**t is about to get serious. The make-up of this esteemed panel includes the tri-country turkey basting champion from Rebersburg PA, a state inspector from the top turkey-growing state of Minnesota (I too thought it was North Carolina…I guess the frigid weather saves on freezing costs), a decorated Blue Ribbon Panelist from Shickshinny, PA who has served on over 30 Blue Ribbon Panels, a faculty member who did not want to share NIL information (name, image, likeness) without proper compensation, a bearded guy named Jeb, and a few others who were loitering in the hall. 

They are ready, so let’s get on to it.

Stuffing vs Dressing? Some call it stuffing. Some call it dressing. Some people say it depends on whether it is in the bird, stuffing, or cooked as a casserole, dressing. However, it is the same stuff, regardless.  What you call it depend on where you are from….a regional thing. So to settle this, we go to a source that knows no boundary….Walmart. We took a look at the bags of product sold at Walmart (including Martin’s Stuffing Cubes and Pepperidge Farms Stuffing Mix) and what do you notice….these bags are labeled stuffing. And the listed directions do not have different names for how it is made….that is, whether making it inside the bird or doing it straight up in the casserole dish, they call it stuffing. 

Blue Ribbon Panel – Stuffing.

FDA Warning Letter Issued to Bakery for Lack of Allergen Preventive Controls

FDA issued a Warning Letter to a Chicago bakery, Third Synthesis Inc., dba Chicago Sweet Connections, Inc..  FDA determined that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility were adulterated within the meaning of the regulation because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been 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. 

The facility did not consider allergens a significant hazard within the food safety plan although the "facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production." FDA concluded "Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control."  Further, "Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg."

Another issue with the Food Safety Plan was not utilizing a Sanitation Preventive Control for pathogens in post-process environment.  The report also criticizes the plan development for not identifying mycotoxins as a hazard in the hazard analysis.

There were also a number of label design issues that resulted in a number of products being mislabeled.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/third-synthesis-inc-dba-chicago-sweet-connections-inc-633453-09062022
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 — SEPTEMBER 06, 2022

Recipient:
Anthanasios Kailis
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
United States

FDA Issues Warning Letters to Food Importers for Lack of FSVP

FDA issued a number of Warning Letters to food importers for not having FSVP in place for their imported products.  These are for the first two weeks in September, 2022.

Kuzmir Imports Inc., of  Hillburn, New York was not in compliance with the requirements of 21 CFR part 1, subpart L for the following importee foods: mini soup croutons onion garlic from your foreign supplier (b)(4) located in (b)(4); nougat spread from your foreign supplier (b)(4) located in (b)(4); and cashews from your foreign supplier (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kuzmir-imports-inc-633082-08022022

Mexia Pallets LLC of  San Juan, Texas did not develop, maintain, and follow a FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the imported food products, including each of the following food products:
Persian limes imported from (b)(4), located in (b)(4)
Apple soft drink imported from (b)(4), located in (b)(4)
Orange soft drink imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mexia-pallets-llc-633369-08162022

Visvita Corporation of Santa Fe Springs, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any foods that the company import, including the following foods:
Visvita Chia Drink - Guanabana Flavour imported from (b)(4), located in (b)(4).
Aloe Vera Drink - Pomegranate Flavor imported from (b)(4), located in (b)(4).
Cold Brew Coffee Powder imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/visvita-corporation-633747-08232022

Mercado Hispano Distributors, pf Tucker, GA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the firm did not develop an FSVP for any of the foods they import, including each of the following:
(b)(4) Cola and (b)(4) Manzana imported from (b)(4), located in (b)(4)
(b)(4) Grapefruit imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercado-hispano-distributors-llc-634708-08022022

Mina Global Trading Corp, of  Matawan - "As a very small importer, for each food you import, you did not obtain written assurance in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mina-global-trading-corp-636140-08082022

Bharat Ratan LLC. of  Renton, WA id not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically. the company did not develop, maintain, and follow an FSVP for any of the foods imported, including:
Fenugreek leaves, Gur Rewri (Sesame Brittle), and Punjabi Biscuit, imported from (b)(4), located in (b)(4)
Meat Masala (Curry Spice Mix) imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bharat-ratan-llc-634674-08222022

BLUE STONE IMPORT USA INC of Manhasset, NY did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop an FSVP for any of the food products imported, including each of the following foods:
(b)(4) Spicy Chicken Flavor Ramen ((b)(4)) from (b)(4), located in (b)(4)
Wheat Flour from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-stone-import-usa-inc-636668-08032022

Jones Affiliated IncCerritos, CA did not develop an FSVP for any of the foods  imported, including:
Wild Yam Flavor Powder, imported from (b)(4) located in (b)(4)
Premium White Gourd Jam, imported from (b)(4) located in (b)(4)
Red Bean Paste, imported from (b)(4) located in (b)(4)
Black Sesame Powder, imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jones-affiliated-inc-639035-0823202

Employees Provide Statements on Facility that Produced Frozen Pizza That Was Linked to E. coli Outbreak

This is an interesting read involving an E.coli outbreak in France related to frozen pizza.  The outbreak occurred earlier this year where more than 70 people came down with infections from pathogenic E.coli.  In the article below, employees provided testimonials to how the facility was run.   One could see that food safety was not the primary driver for operating decisions.   

While the cause of the outbreak was not found, the investigation revealed deficiencies in the management of the plant.  This included the "presence of mold, rust and peeling paints was then discovered in the factory, as well as food moths on the production line of Fraîch'Up pizzas."

What employees stated:

"In 2012, Nestlé introduced a new way of managing the site. This is called the Lean method, explains Maryse Tréton of the CGT federation of agri-food. The goal is to minimize all times that are not dedicated to production. We reduce cleaning times and preventive maintenance times to make production as possible."

"Three years later, in 2015, this reduction in cleaning time will be included in a so-called "competitiveness" plan. "Until 2015, the plant operated with 16 hours of production and 8 hours of cleaning per day," say Patrick and Pierre. After 2015, we almost double the production time to 27 hours a day (in three 9-hour shifts) and we almost halve the cleaning time from 8 hours to 4 hours 45.""

"According to them, the consequences of this reorganization are not long in coming: "For us, it meant going faster on cleaning. So, the priority was to clean the production line and the machines. But not what was around, such as the walls and ceilings. It was no longer possible to do everything." Asked about this, the management of Nestlé France confirms that the cleaning time is now less than 5 hours. But it specifies that it has "systematic microbiological samples carried out in different strategic areas of the site"."

"This reduction in cleaning time would have had other consequences. According to the employees whom Radio France's Investigation Unit met, some areas of the factory that were cleaned at least once a year before 2015 would no longer be cleaned. "Before," explains one of them, "we closed the factory for three weeks in August. Meanwhile, the cleaning company that had a contract with the factory could do bottom cleaning. Since then, Nestlé only wants to stop the factory for one week in the summer. So the general condition has deteriorated.""

Some of the outcomes:

• The air conditioning (filtering) system was not cleaned at necessary frequency.
• Flour silos not cleaned for seven years.
• Presence of rodents
• Change of flour to untreated flour where facility had been using pasteurized flour.

What is difficult to tell is to what degree the plant culture, being in France, resisted to more of a US based way of manufacturing.  That is, you can run a lean system provided the necessary procedures are still completed.  Clearly, important activities were not completed and employees had not bought into the lean manufacturing approach.

ICI - France
https://www.francebleu.fr/infos/faits-divers-justice/affaire-buitoni-de-nouveaux-temoignages-accablent-la-direction-1662724306
Buitoni case: new testimonies overwhelm management

Saturday September 10th, 2022 at 6:07 AM - Par Laetitia Cherel, France Bleu, France Bleu Nord

The testimonies of several employees of the Buitoni factory in Caudry shed light on the health deficiencies observed in their factory. They denounce a reduction in cleaning time imposed in 2015 and a change of flour in 2021. Investigation by Laetitia Cherel, investigation unit of Radio France.

FDA Provides Investigation Update into Illnesses Related to French Lentil & Leek Crumbles, Exact Cause Not Yet Identified

Close to two months have passed since Daily Harvest French Lentil & Leek Crumbles were linked to complaints of gastrointestinal illness and abnormal liver function. At this point, there have been an estimated 369 cases with 125 resulting in hospitalizations.

One ingredient, Tara Flour, had been indented as the source, but how it caused the illness has not yet been detailed.


https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-adverse-event-reports-french-lentil-leek-crumbles-june-2022
Investigation of Adverse Event Reports: French Lentil & Leek Crumbles (June 2022)

Do not eat, sell, or serve recalled French Lentil & Leek Crumbles from Daily Harvest. FDA’s investigation is ongoing.

Case Counts
Total Adverse Illness Events: 369*
Hospitalizations: 125*
Deaths: 0
Last illness onset: August 9, 2022*
States with Adverse Illness Events: AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, MD, MA, MN, MS, MI, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CAERs reports received by the FDA

Outbreak Case Counts Increase for Daily Harvest's Lentil and Leek Crumbles, Tara Flour Identified as Cause

As last reported by FDA on 7/28/22 on a disease outbreak associated with Daily Harvest's Lentil and Leeks Crumble, there have been 329 illness events with 113 hospitalized.  The cause of the outbreak has been identified as the Tara Flour, but there is little more information than that.

Case Counts
Total Adverse Illness Events: 329*
Hospitalizations: 113*
Deaths: 0
Last illness onset: July 16, 2022*
States with Adverse Illness Events: AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, MD, MA, MN, MS, MI, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CAERs reports received by the FDA


https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-adverse-event-reports-french-lentil-leek-crumbles-june-2022?utm_medium=email&utm_source=govdelivery#contact
Investigation of Adverse Event Reports: French Lentil & Leek Crumbles (June 2022)

NY Company Recalls Gluten Free Cookies for Containing Gluten Due to Ingredient

Sweet Loren’s of New York, NY is voluntarily recalling a single lot code of Sweet Loren’s Sugar Cookie Dough 12oz, because it may contain traces of gluten in product labeled as gluten free.   This issue was identified through testing of the product in-house. The oat flour used was determined to have traces of gluten despite having documentation (COA) declaring it to be gluten free.

Can you rely just on a COA (certificate of analysis)?  Too often, receiving an acceptable COA is the extent of a company's supplier control program.  Clearly, this ingredient needs to be addressed with a Supplier Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sweet-lorens-inc-issues-voluntary-allergy-alert-undeclared-gluten-product
Sweet Loren’s, Inc Issues Voluntary Allergy Alert On Undeclared Gluten in Product
Summary
Company Announcement Date:  July 16, 2022
FDA Publish Date:  July 18, 2022
Product Type:  Food & Beverages  Bakery Product/Mix  
Reason for Announcement:  Undeclared gluten
Company Name:  Sweet Loren’s
Brand Name:  Sweet Loren’s
Product Description:  Sugar cookie dough

FDA Issues Companies Warning Letters to Importers for Not Having FSVP for Imported Foods

FDA issued Warning Letters to the following Importers for not having FSVP for imported foods.

SDJJ Distributors of National City, CA did not develop, maintain, and follow an FSVP for any of the food imported products including: Tamarind-Mango Flavored Soft Candy, Caramelo Mix and Jilote.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sdjj-distributors-626282-06062022

Winfull Corporation of Houston, TX id not develop, maintain, and follow an FSVP for any of the company's imported foods including: AA Grade Grass Jelly Drink Beverage Base, Passion Fruit with Pulp Syrup from (b)(4), and Kidney Beans.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/winfull-corporation-629870-06092022

Fresh Imports International LLC, of Hidalgo, TX did not develop an FSVP for any of the company's imported foods including Fresh avocados, Fresh pineapples, and Fresh avocados
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresh-imports-international-llc-627330-05042022

Daxa Foods, Inc. dba India Grocers of Edison, NJ you did not develop an FSVP for any of the imported foods including Puffed Rice, Rice flour and Shredded Coconut.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/daxa-foods-inc-dba-india-grocers-631619-05312022

FDA Issues Warning Letters to Five Importers for Not Developing FSVP

FDA issued Warning Letters to five food imports for not developing, maintaining, and implementing an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).   FSVP is required for food importers to ensure that their foreign producers are meeting same standards required in the US.

Lempira Distribution LLC of. Miami, FL did not develop FSVPs for the imported food products including, but not limited to:
Banana Soft Drink, imported from (b)(4), located in (b)(4).
Sweet Bread, imported from (b)(4), located in (b)(4).
Plantain Chips, imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lempira-distribution-llc-616514-11032021

LECS USA, Inc. of Los Angeles, CA did not develop an FSVP for any of their imported foods including Green Tea

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lecs-usa-inc-623164-03282022

Fres Co, LLC of Bronx, NY did not develop an FSVP for any of the their imported foods including the following:
Fresh plantains from (b)(4)
Fresh mangoes from (b)(4)
Tomatoes from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fres-co-llc-627216-04182022

El Dorado Imports Inc of Spring, Texas. did not develop an FSVP for any of their imported food products  including:
Coconut candy imported from (b)(4)
Sugar baked flour tortillas imported from (b)(4)
Sweet bread with pineapple imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-dorado-imports-inc-626870-04262022

Triple J Fresh, LLC of McAllen, Texas did not develop an FSVP for any of their imported foods including:

Fresh broccoli and fresh coriander imported from (b)(4), located in (b)(4), and 

Fresh Persian limes imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/triple-j-fresh-llc-627680-04252022

TX Establishment Expands Recall of Tortillas for Undeclared Wheat and Milk

The Salsa Texan of Flower Mound, Texas is expanding an earlier recall to include all regular and burrito sized packages of tortillas labeled as Coconut Flour Tortillas and Blended Flour Tortillas because they may contain undeclared wheat and milk. The voluntary recall was initiated after it was discovered that the tortillas were distributed in packaging that did not reveal the presence of wheat or milk.  The initial recall was issued on March 18, 2022.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-and-recall-expansion-undeclared-wheat-and-milk-tortillas
The Salsa Texan Issues Allergy Alert and Recall Expansion for Undeclared Wheat and Milk in Tortillas
Summary
Company Announcement Date:  April 15, 2022
FDA Publish Date:  April 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and milk
Company Name:  The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:  Tortillas

Gluten-Free Coconut Flour Tortillas Recalled After Wheat-containing Product in Packages

The Salsa Texan of Flower Mound, Texas is voluntarily recalling its regular and burrito sized packages of Coconut Flour Tortillas because they may contain undeclared wheat. The voluntary recall was initiated after it was discovered that the wheat containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-undeclared-wheat-contamination-gluten-free-coconut-flour-tortillas
The Salsa Texan Issues Allergy Alert on Undeclared Wheat Contamination in “Gluten Free Coconut Flour Tortillas”
Summary
Company Announcement Date:  March 18, 2022
FDA Publish Date:  March 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:   The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:   Coconut Flour Tortillas

OH Firm Recalls 'Einkorn' Products for Not Declaring Wheat Because Einkorn is Wheat

Stutzman Farms of Millersburg, Ohio is voluntarily recalling all products containing einkorn as the product labels do not declare wheat, a known allergen, on the product label. Stutzman Farms became aware of the misbranding issue after it was brought to our attention by the Ohio Department of Agriculture.

From the Einkorn.com website "Einkorn is the oldest wheat known to scientists, and is considered man’s first wheat. The term einkorn is derived from the German language and interpreted to mean “single grain”. Einkorn wheat is known in taxonomy as either Triticum boeoticum (wild wheat), or Triticum monococcum (domesticated species). Domesticated and wild forms of wheat may be considered either as separate species, or as Triticum monococcum’s subspecies."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stutzman-farms-issues-voluntary-recall-its-einkorn-products-undeclared-wheat-allergen
Stutzman Farms Issues a Voluntary Recall of its Einkorn Products for an Undeclared Wheat Allergen
Summary
Company Announcement Date:  March 08, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Stutzman Farms
Brand Name:  Stutzman Farms
Product Description:  Products containing einkorn: berries, flour, pretzel, more.

NJ Importer Issued Warning Letter for Not Having FSVP

FDA issued a Warning Letter to Patidar Trade, Inc. of North Brunswick, NJ because they were in violoation fo teh Foreign Supplier Verification Program Regulation (FSVP) which requires companies to conduct a hazard analysis and enact verification procedures for items that are imported.  The comany did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop, maintain, and follow an FSVP for any of the imported foods including each of the following food products:

Wheat flour imported from (b)(4)

Rice flour imported from (b)(4)

Phool makhana imported from (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/patidar-trade-inc-619282-01062022
Patidar Trade, Inc.
MARCS-CMS 619282 — JANUARY 06, 2022

FDA Warning Letter Issued to Kansas Bakery for Significant GMP Issues

FDA issued a Warning Letter to a Kansas Bakery after an extended inspection in August of 2021.  The company had not issued a response to the observations that were noted on the  Inspection Form 483.

There are a number of issues cited under each of these items.
Item 1 - Lots of bugs including cockroaches and flies.
Item 2 - Really dirty equipment

Item 3 - Poor employee practices when working with RTE foods

Looking at the facility on Google Street View, it is hard to believe that FDA was able to find this shack-like building.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakery-project-inc-dba-delano-bakery-617718-01042022
Bakery Project Inc. dba Delano Bakery
MARCS-CMS 617718 — JANUARY 04, 2022

Iowa Creamery Issued Warning Letter for Not Knowing How to Label Food Products Properly

FDA issued a Warning Letter to Picket Fence Creamer of Woodward, Iowa after finding twelve flavors of ice cream and three flavors of cheese curds contained undeclared ingredients and sub-ingredients.  From the notice, the company failed to identify ingredients and also failed to detail the makeup of certain ingredients (listing the sub-ingredients).  Makes you wonder if they were controlling allergens from product to product.

While a small farm producer, they were distributing their food items to retail stores.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/picket-fence-creamery-llc-618726-01142022
Picket Fence Creamery LLC

MARCS-CMS 618726 — JANUARY 14, 2022

FDA Warning Letter - Illinois Food Repacking and Distribution Facility

FDA issued a Warning Letter to International Golden Foods, a repackaging and storage facility, located in Bensenville, IL.  The company repackages a variety of ready-to-eat (RTE) foods (e.g., tree nuts, seeds, and dried herbs and spices) and non-RTE foods (e.g., milled rice, rice flour, dried pasta, and wheat flour). The facility also stores and distributes RTE soft fresh cheeses (e.g., feta cheese and goat’s milk cheese) and pre-packaged ready-to-eat food products (e.g., tahini, grilled eggplant, pickles, dates, and figs). 

The company did not prepare, or have prepared, and did not implement a food safety plan, as required by regulation.  Preventive Controls were not in place including Allergen Preventive Controls.

From a facility and operational standpoint, there were some major issues including:

• cheeses stored at incorrect temperatures (>59F)
•  a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. 
• a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. 

From the company's website, we can see an importer who distributes international products.  They also repack these items to meet retail client needs.  So often we see distributors who decide to repack items without considering regulations.

FDA WARNING LETTER
International Golden Foods Inc - 619417 - 12/15/2021 | FDA
International Golden Foods Inc
MARCS-CMS 619417 — DECEMBER 15, 2021

Dough Sheet Products Fail to State Wheat on the Label Resulting In Allergen Related Recall

Local Fixe LLC of Roseburg, Oregon is recalling Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink - Fettucine, and Fresh Flour Tortillas because it may contain undeclared wheat.
The recall was initiated after it was discovered that products containing undeclared wheat or gluten were distributed in packaging that did not reveal the presence of wheat or gluten. 

The ingredient statement for the Classic Lasagna Sheets states:

Ingredients: Flour, Semolina, Egg, Water

The other labels are similar in that none of them state Wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/local-fixe-llc-issues-allergy-alert-undeclared-wheat-classic-lasagna-sheets-soup-noodles-dinner
Local Fixe LLC Issues Allergy Alert on Undeclared Wheat in Classic Lasagna Sheets, Soup Noodles, Dinner Rolls, Pie Dough, Squid Ink – Fettucine, and Fresh Flour Tortillas
Summary
Company Announcement Date:  December 22, 2021
FDA Publish Date:  December 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Local Fixe LLC
Brand Name:  Local Fixe LLC

FDA Warning Letter - Small Family-run Tortilla Company Still Does Not Have Food Safety Plan

What happens when the FDA gives you a chance to write your food safety plan and you don't do it - they issue you a Warning Letter.  Sarita's Tortilla Factory, Inc, a small company located in Eagle Pass TX had an inspection in July of 2019, during which, the company stated that they would write a Food Safety Plan.   During reinspection in July of 2021, there was no plan.   So FDA issued a Warning Letter to the company for not having a Food Safety Plan as required by regulation.

In addition, a number of GMPs were listed on the Warning Letter.  These include:

• Water was dripping from a ceiling with peeling paint onto a pallet of (b)(4)-(b)(4) bags of flour.
• Filth was present on metal air vents and fans located directly above RTE soft flour and corn tortillas.
• There were no procedures to ensure cleaning compounds and sanitizing agents are safe and adequate
• A live frog was inside the raw ingredients room, under a pallet of wheat flour. The frog was observed to enter the facility through a gap in the loading bay door.
• An unscreened door was open at the north side of the facility during the production of soft flour and corn tortillas.
• There were gaps along two screened doors located in your facility’s loading areas on the northeast side and west side of the building.
• An employee inserted an approximately 12-inch piece of splinted wood into corn tortilla dough 
• Used non-food-grade grease on tortilla production equipment.

From the company's Facebook page, it seems to be a very nice, small family run company that has been in business for at least four years.  But as we have seen with other small companies that move beyond retail sales into further distribution, they now fall under the Federal regulations. While GMPs must be adheere to for all food operations, the step up to writing and implementing a Food Safety Plan can be a challenge, but one that can be overcome, and needs to be overcome.  Or in this case, the company may file as a Qualified Facility, depending on the amount of sales. 

Sarita's Tortilla Factory, Inc - 617384 - 11/22/2021 | FDA
Sarita's Tortilla Factory, Inc

Crackers Recalled After Packaging Error Of Cheddar Crackers Packed into Wrong Boxes Results in Undeclared Dairy

Simple Mills, based in Chicago Illinois, is initiating a voluntary recall because a select number of Fine Ground Sea Salt Almond Flour Cracker boxes were erroneously packed with bags of Farmhouse Cheddar Almond Flour Crackers. As a result, the packaging does not list the presence of a possible allergen (milk). 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/simple-mills-issues-voluntary-recall-select-number-lots-fine-ground-sea-salt-almond-flour-crackers
Simple Mills Issues Voluntary Recall on a Select Number of Lots of Fine Ground Sea Salt Almond Flour Crackers Due to the Presence of Undeclared Milk
Summary
Company Announcement Date:  October 06, 2021
FDA Publish Date:  October 07, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Simple Mills
Brand Name:  Simple Mills
Product Description:  Fine Ground Sea Salt Almond Flour Crackers