FDA Issues Warning Letter to OH Bakery for Being Nasty

An Ohio bakery [located close to Ohio State University by the way] was cited for lots of bad stuff.  As we have seen in recent Warning Letters, bakeries have been slammed for many GMP issues.  The reason for this is that many have not had FDA visits.  They were often inspected only by the State and often viewed as low risk.  As we have learned more about the potential for Salmonella to be in flour and to persist in dry facilities for long periods of time, the risk in bakeries has come more to light.  In this case, the issues with improper cleaning leading to dust buildup is a concern, as well as employee hygiene issues.  Allergens are another concern where multiple allergens may be used.  Finally Staphylococcus is a concern when cream fillings are temperature abused. 

And now we are seeing here where a lack of a food safety plan (HACCP-based) is noted as well.

No Food Safety Plan - "Specifically, you did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in your central kitchen, such as RTE cream-filled eclair pastries, as required by 21 CFR § 117.126. Based on your operation, when you perform your hazard analysis you should consider hazards including contamination of products with environmental pathogens, such as Listeria monocytogenes and Salmonella, and food allergens."

Equipment not food safe - "our investigator observed a stainless-steel mixing bowl with rough welds and dents on the inside of the bowl, which make it a surface that is not easily cleanable and that can harbor pathogens or allergen-containing food debris."

Improper cleaning - Dust build-up was observed 1) on the fan covers of the cooling unit in the quiche freezer, dairy cooler, pastry cooler, and bread freezer  Finished product was stored uncovered in these coolers and freezers); 2)on the blower vent of the air conditioning unit (Racks of bread were stored below the vent to cool); 3) on the air filter bracket above the rotary oven and retail prep area.  Clean pots and containers were stored below this filter.  and 4) on electrical cords and electrical outlets directly above the pastry prep table.

Employee hygiene issues -  1) An employee was observed not wearing a beard net while placing fruit on top of fruit tarts; 2)the employee's shirt was touching some of the tarts; 3) An employee was observed wearing jewelry (a bracelet made of string) while making bread dough. 4) Employees' personal items, including coffee cups and shake containers, were stored under prep tables in the manufacturing areas.  An employee was observed taking a drink of the coffee stored under the prep table and then continued prepping pastries without washing their hands. 5) An employee, who was observed filling eclairs with cream, was handed their cell phone, which was found on the floor, the employee placed the cell phone in their back pocket and continued to fill eclairs with cream, without washing their hands. 6) An employee loading a truck for delivery... picked up a cake from the tray, touched the cake with his fingers, and placed the cake into a box.  The employee did not wash their hands before touching the cake. 

Temperature Control -  Your dairy cooler is used to store dairy products, such as heavy whipping cream, pasteurized liquid egg, milk, pastry cream, chocolate ganache, and sweet dough, all of which are used to manufacture RTE pastries.  You stated you visually inspect the temperature of the cooler (b)(4) and record it on the Cooler and Freezer Temperature record.  From December 31, 2017 to June 2, 2018, your records show 104 out of 153 (b)(4) where the temperature of the cooler was recorded above _____°F, reaching as high as ____°F.

FDA Inspections, Compliance, Enforcement, and Criminal Investigations
Warning Letter
LaMarquise Inc. 2/5/19

Two Recalls Issued After Complaints of Foreign Material in the Form of Metal Pieces

There were two recalls of meat related to foreign material in the product, specifically metal pieces.  In  the recall from the NH establishment, the recall was issued after FSIS inspectors found, through their record review, that the company had received consumer complaints for metal. In the other case, complaints for metal were made directly to USDA.

North Country Smokehouse, a Claremont, N.H. establishment, is recalling approximately 2,686 pounds of ready-to-eat sausage products that may be contaminated with extraneous materials, specifically metal,  The problem was discovered on March 18, 2019 by FSIS inspection program personnel during a routine review of establishment consumer complaint records.

Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 69,093 pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal.  The problem was discovered when FSIS received two consumer complaints of extraneous material in the chicken strip products.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-037-2019-release
North Country Smokehouse Recalls Ready-To-Eat Sausage Products due to Possible Foreign Matter Contamination
Class I Recall
037-2019
Health Risk: High
Mar 23, 2019

Avocados from CA Recalled After Environmental Samples Positive for Listeria

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

Pet Food Company Expands Recall for Elevated Vitamin D

Hill’s Pet Nutrition is expanding its recall of select canned dog food products due to elevated levels of vitamin D, an issue that was caused by the same vitamin premix received from a U.S. supplier that was the issue that led to a recall in January.   "Pet Nutrition learned of the potential for elevated vitamin D levels in some of our canned dog foods after receiving a complaint in the United States about a dog exhibiting signs of elevated vitamin D levels. Our investigation confirmed elevated levels of vitamin D due to a supplier error."

From the recall notice, "Following that recall, we conducted a detailed review of all canned dog foods potentially impacted by the vitamin premix with elevated levels of vitamin D. This review included: analyzing consumer complaints; reviewing veterinarian medical consultations; auditing our supplier; and reviewing our own manufacturing and quality procedures. We then did additional product testing to ensure we had taken all appropriate action. Our review determined that there were additional products affected by that vitamin premix, and it is for that reason that we are expanding the recall. Hill’s has received a limited number of complaints of pet illness related to some of these products."

https://www.fda.gov/Safety/Recalls/ucm634087.htm
Hill’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D
For Immediate Release
March 20, 2019

USDA FSIS Releases Guidance on Responding to Consumer Complaints for Meat and Poultry Operations

USDA FSIS released a 'best practices' for handling customer complaints for meat and poultry operations.  This was issued after the numerous complaints of foreign objects 

"The purpose of this guideline is to provide industry with reference material on best practices for responding to customer complaints of adulterated and misbranded meat and poultry products.  FSIS developed this document in response to an increase in the number of recalls of meat and poultry products adulterated with foreign materials.  In many cases, the recalling establishments had received multiple customer complaints prior to these recalls." 

By regulation, firms are to notify USDA FSIS if the firm finds the product is adulterated.  So technically, if complaints are received that there is a foreign material, the product is adulterated.  This is to be done within 24hrs.

What are the notification requirements under 9 CFR 418.2? §418.2  Notification.
Each official establishment must promptly notify the local FSIS District Office within 24 hours of learning or determining that an adulterated or misbranded meat, meat food, poultry, or poultry product received by or originating from the official establishment has entered commerce, if the official establishment believes or has reason to believe that this has happened. The official establishment must inform the District Office of the type, amount, origin, and destination of the adulterated or misbranded product. 

Highlights from the document - https://www.fsis.usda.gov/wps/wcm/connect/8d0a0e73-1e6f-424f-a41f-ea942247a5ff/Guideline-for-Industry-Response-Customer-Complaint.pdf?MOD=AJPERES

This Week in Mislabeled Product for Week Ending March 16, 2019

Someone Misses the Fact that Gluten is in Wheat - North Country Smokehouse, a Claremont, N.H. establishment, is recalling approximately 2,601 pounds of pork sausage products due to misbranding,The product has a gluten free claim represented on the front of the label; however, the product contains gluten in the form of wheat.  The problem was discovered on March 11, 2019 when the firm notified FSIS that they received a consumer complaint. [Marketing Dept?]

Soy Missed on Label - Carnivore Meat Company, LLC, a Franklin, Tenn. establishment, is recalling approximately 379 pounds of raw ground beef and pork sausage products due to misbranding and undeclared allergens - the products contain soy.  The problem was discovered on March 12, 2019 by FSIS personnel during a food safety assessment at the establishment.

Inspectors Find that Milk is Not Listed on Label - Choice Canning Company, Inc., a Pittston, Pa. establishment, is recalling approximately 35,459 pounds of chicken fried rice products due to misbranding and undeclared allergens, - the products contain milk, a known allergen, which is not declared on the product label. The problem was discovered on March 11, 2019 by FSIS personnel during routine label verification.

FDA Issues Recall Notice on Flour Recall for Salmonella

After reports of Pillsbury Flour was issued last week, FDA issued an announcement on March 12th, that Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241)because it may be contaminated with Salmonella.  There have been no reports of any illnesses associated with this recall. Product is being recalled out of an abundance of caution.

No specific information was provided on how the contamination was detected.

FDA added the reminder that flour is a raw product - "Flour is made from wheat that is minimally processed. Flour should not be considered a ready-to-eat product. It is an ingredient for baked, fried, and cooked products, and these heating processes ensure the safety of flour with proper handling. All surfaces and utensils should be properly cleaned after contact with flour or uncooked dough or batter. Consumers should wash their hands after handling flour or uncooked dough or batter. Consumers should not eat uncooked dough or batter made with raw flour. If you think you became sick from a food containing flour as an ingredient, please call your healthcare provider."

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk
For Immediate Release
March 12, 2019

PR Establishment Recalls Breaded Chicken Patty Product Due to Complaint of Piece of Metal

Puerto Rico establishment, is recalling approximately 35,870 pounds of breaded chicken patty products that may be contaminated with extraneous materials, specifically pieces of metal,  The problem was discovered on March 11, 2019 after the firm received a consumer complaint from a school that received the product.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-031-2019-release
Productos La Aguadillana, Inc. Recalls Breaded Chicken Products Due to Possible Foreign Matter Contamination
Class I Recall 

031-2019
Health Risk:High 

Mar 14, 2019

RTE Meat Snacks Recalled Due to Potential Product Tampering

Monogram Meat Snacks, LLC, a Martinsville, Va. establishment, is recalling approximately 191,928 pounds of ready-to-eat pork sausage products that may be adulterated due to possible product contamination, according to the report, "initiated due to product tampering, following the production process."

No further information is available at this time including how it was discovered.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-029-2019-release
Monogram Meat Snacks, LLC Recalls Pork Sausage Products Due to Possible Product Contamination
Class I Recall
029-2019 
Health Risk:High 
Mar 13, 2019