FDA Warning Letter - Bakery with Listeria Issues

FDA issued a warning letter to an Indiana bakery after "investigators found serious violations of the [GMPs and Preventive Controls Regulations]. Additionally, FDA collected environmental samples (i.e., swabs) from various areas in [the] 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 strains found during FDA inspections in 2018 and 2016"

The facility was producing croissants, and not that those have a history as a vehicle of Listeria, never the less, the organism had been found in the facility in subsequent inspections as well as the current.  It appears that the cleaning of the facility was not very good, thus allowing the Listeria to persist over time.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cafe-valley-bakery-llc-603875-03182020
WARNING LETTER
Cafe Valley Bakery, LLC
MARCS-CMS 603875 — March 18, 2020

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

Ritz Crackers, Gold Fish, Bread, and Swiss Rolls Recalled After Using Whey Powder Found to Contain Salmonella

 After finding Salmonella in whey powder, a supplier's recall has impacted companies making baked products.  First, Mondelez recalled Ritz cracker sandwiches and bits.  Pepperidge Farms is recalling Goldfish crackers.   A Georgia bakery is recalling Swiss Rolls and bread products after using whey product found to contain Salmonella.

The whey powder is an ingredient used in the manufacture of the product.  This ingredient was produced by Associated Milk Producers.

One would expect that Salmonella in the flour would be destroyed in the baking process, so the risk could be considered minimal.  These recalls are done as an extreme precaution.

Huffington Post
https://www.huffingtonpost.com/entry/ritz-goldfish-salmonella-recall_us_5b56ba3de4b0fd5c73c84b22
U.S. NEWS
07/24/2018 06:02 am ET 
Ritz Bits, Goldfish Crackers Recalled Over Salmonella Fears
The recalls were prompted by possibly contaminated whey powder.

NC Firm Recalls Mini Eclairs After Positive Listeria Sample

A NC establishment is issuing a voluntary recall of selected mini eclair products that were made over a 5 day period (March 5-9, 2018) because they have the potential to be contaminated with Listeria monocytogenes,  "The recall was a result of a routine sampling program by the company which revealed that finished product ran on the same line contained the bacteria. The company did not release any product that tested positive for Listeria monocytogenes and as a precautionary measure is recalling all product ran on the line during that production week."  No illnesses have been reported.

Poppies International, Inc. Recalls Delizza Belgian Custard Cream Mini Eclairs 30 Count, Due to Potential Health Risks
For Immediate Release
March 23, 2018

FDA Warning Letter - Bakery with 'Love' Listed in Ingredient Statement - Nasty Food Operations Exposed

A MA bakery received a Warning Letter from FDA.  While the bakery violated most all basic GMPs, the one item that has caught the eye of the press is the fact the the company listed 'love' as an ingredient.  "Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."  But this was just a minor issue compared to the vast array of GMP violations.  That is, unless they refer to nastiness as 'love',..,..then there was plenty.

Now, if I am overseeing a bread operation, and seeing this as well as this Warning Letter in August for a NM bakery, I am getting a sense that FDA will probably be looking at bakeries a little more critically than they have in the past, and thus, it may be time to tighten up the ship a bit more.

There were a ton of issues, but as a sampling:

• Food residue on equipment that was stated as being clean and sanitized including "empty color-coded barrels designated for use with different allergens including tree nuts and cheese with apparent dough residue inside and out, and stacked inside one another."  It was stated that the "firm does not have a procedure or production schedule to ensure cleaning and sanitation is done before production or in between changes to prevent cross-contamination of different allergen products."
• Failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing  - bread residues on screens, totes, etc.
• failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition - ceilings, air intakes etc coated with stuff.
• Failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination
• failed to provide, where necessary, adequate screening or other protection against pests - flies and crawing bug in processing area.
• Personnel not following basic GMPs. - wearing jewelry, eating in operational areas.

FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577393.htm
Office of Human and Animal Food Operations East
Division 1

WARNING LETTER
CMS# 532236

Nashoba Brook Bakery, LLC 9/22/17
September 22, 2017

A NM Bakery Issued a Warning Letter - Issues with Sanitation and Lack of Management Training

A New Mexico bakery was issued a warning letter from the FDA.  Most of the issues cited involved basic sanitation, and they were issues that were also noted in a 2014 inspection...thus the issuance of the Warning Letter.  To look at the facility from Google Street view (below), it looks like a legit operation (compared to this)

Many bakeries may be new to FDA inspections, although it was noted that this firm had a previous FDA inspection in 2014 (and unfortunately, didn't make much progress from that time...or so it seems).  But one of the items that is most interesting involves training, or the lack of training, specifically of management (see further down).

• Unsanitary condition noted on 1) walls, overhead door, and cooling fan in areas used to cool baked bread., 2) condenser fans and support pole in walk-in refrigerator used to store uncovered apple pies, and 3)  3-Compartment sink used to clean in process equipment.
• Peeling paint in the incoming supply room above ingredient containers which had broken lids, no lids, lids not fully covering materials. Additionally, peeling paint was observed on the ceiling of the walk-in refrigerator used to store uncovered apple pies.  
• Fresh and dried dough on the ceiling above an uncovered mixer and along the rim of the (b)(4) bucket. (b)(4) is used as a processing aid in the production. 
• Condensation issues  with buildup inside the proofing  along the ceiling, sides of walls, and along the door frame. As the uncovered dough enters the  proofing (b)(4), condensation drips directly onto uncovered dough.  Dark brown condensation buildup was observed in the production area on the ceiling above the proofing  and the final bread rolling area.  Condensation buildup was observed in the walk-in freezer fans located above finished product.
• Inadequate screening or other protection against pests - the outer door and warehouse garage doors were open during food production activities without adequate protection to prevent entry of pests into the production facility.
• The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment - the 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. Utensils were then immediately used without allowing them to air dry. At the final dough, recently used trays covered with residue were slammed on the floor to remove particles and then placed onto the cart, without washing, to be reused. Our investigator observed fresh dough immediately placed on these trays and sent to proofing .   In the proof , there is no evidence that the conveyor trays used to transport the dough from the extruder to the are sanitized.  The firm’s water filters have not been changed since 2013. There was dark brown and slimy residue in the filter. The filtered water is used in the production of dough, to clean large pieces of equipment, and used in the 3-compartment sink.

But this is the item to note - "Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). Specifically:

•  The production manager did not know the correct order of operation to properly clean and sanitize utensils at the 3-compartment sink. The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. During the inspection, the rinse water was observed to be cloudy and dirty, providing a possible source of cross-contamination.
• The production manager did not know what the adequate sanitizer concentration should be; there were no test strips available to verify the concentration, and he relied solely on placing one capful of bleach into water
• The president of the company lacks basic sanitation knowledge. For example, when asked about the sanitation procedures, he commented on cleaning the floors and was not aware of equipment cleaning and maintenance schedules. He also did not know the required sanitizer concentration and did not provide test strips to employees for verification."

As we know, as part of 21CFR117, it is required that management be adequately trained in food safety.

Finally - the firm failed to provide appropriate training in food handling techniques and food protection principles have not been provided to food handlers 1) an employee touching ready to eat bread rolls with bare hands to determine if they were cool enough for packaging. 2) an employee in the packaging area wearing only one glove, on the right hand. The employee was manually sorting bread into final packaging with both the gloved and bare hands.

FDA Recall Notice
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570807.htm
July 5, 2017
WARNING LETTER
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301

FDA Issues Warning Letter to Bakery

FDA issued a warning letter to a California bakery for...a lot of stuff.

- No allergen control

- Poor cleaning - residual raw dough present after cleaning (and we all know this creates a Salmonella / E. coli growth opportunity).

- Leaky roofs - source of Salmonella and moisture

- Poor pest control - presence of insects, poor protection against entry

- Poor personal hygiene practices - people not wearing hair protection
- Improper labeling

With FSMA, bakeries may be getting more attention than in the past.  Because products are generally considered low risk, they have not received the scrutiny of higher risk products.  However, with issues from allergens to Salmonella in flour/dough, they are not risk free.


Nobel Bakery, Inc. 3/16/17

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549608.htm
WARNING LETTER
March 16, 2017
WL# 19-17
Norik Nikogosyan, President/Co-Owner
Nobel Bakery, Inc.
5638 Cahuenga Blvd.
North Hollywood, CA 91601-2103

Recalls - April 5, 2011

Industry News – PM
Turkey burger recall due to antibiotic-resistant Salmonella strain -
By Chris Scott on 4/5/2011 Meatingplace

The recall of Jennie-O frozen raw turkey burger products is due to the presence of Salmonella Hadar, a strain of the bacteria that is resistant to many commonly prescribed antibiotics.

The Centers for Disease Control is working with USDA's Food Safety and Inspection Service (FSIS) to identify any other illnesses that may be related to the recall, but have not yet been connected with it, according to documents posted on the CDC website.

Authorities are using DNA analysis to identify cases of illness linked to the outbreak, which has affected 12 people ranging in age from 1 year to 86 years old in 10 states. Jennie-O Turkey Store in Willmar, Minn., has recalled nearly 55,000 pounds of frozen raw turkey burger products mainly sold in Sam’s Club stores (See “Turkey burgers recalled on salmonella concerns related to illnesses,” on Meatingplace, April 4, 2011.)

Because the specific strain of Salmonella is resistant to antibiotics, the risk of hospitalization or being unable to treat the resulting illnesses is higher than instances of other outbreaks. The FSIS may also recall additional turkey products as it continues its investigation with the CDC and public health officials in all 10 states, according to the documents

For more information

http://www.cdc.gov/salmonella/hadar0411/040411/index.html

MB - This is a raw product that that is labeled to be cooked by the consumer before consumption. In the cases where illness has occurred, there would need to be a breakdown in consumer handling and preparation practices, either cross-contamination or undercooking. Since this Salmonella strain is resistant to antibiotics, it poses a bigger risk to those who become infected.


As seen with earlier outbreaks, people tend to undercook patties, especially frozen patties where it takes longer for heat penetration to occur into the center of the patty. And as is often done, there are many who rely on color rather than a thermometer for the end-point of the cooking process.



CERTAIN BULK AND PREPACKAGED RAW SHELLED WALNUTS MAY CONTAIN E. coli O157:H7 BACTERIA

Related alerts: 2011-04-04 | 2011-04-03

OTTAWA, April 3, 2011 - The Canadian Food Inspection Agency (CFIA) and Amira Enterprises Inc. are warning the public not to consume certain bulk and prepackaged raw shelled walnut products described below because these products may be contaminated with E. coli O157:H7.

All raw shelled walnuts sold from bulk bins, all package sizes and all lot codes / Best Before dates of the following raw shelled walnuts and products containing walnuts are affected by this alert. The affected products were available for purchase from January 1, 2011, up to and including April 4, 2011. The raw shelled walnuts are imported from the USA.

http://www.inspection.gc.ca/english/corpaffr/recarapp/2011/20110403e.shtml
http://www.marketwire.com/press-release/Public-Advisory-E-coli-Outbreak-1422244.htm

MB - The Canadian consumer advisory advises to cook the walnuts. Surely this opens the opportunity for cross contamination with a highly pathogenic organism. It may have better to advise individuals to throw-out all suspect product.



Salmonella numbers tied to RI bakery rise to 56

Associated Press - April 1, 2011 5:15 PM ET

PROVIDENCE, R.I. (AP) - Fifty-six people have reportedly fallen ill with suspected cases of salmonella amid an outbreak that may be linked to a Rhode Island bakery.

That's up from 39 people as of 3 days ago. The Rhode Island Department of Health said Friday that 26 of those who have reported illness have been hospitalized and 24 have laboratory-confirmed cases of salmonella.

A man in his 80s who had tested positive for salmonella died on March 23.

Officials say many of the affected people ate doughnut-like pastries called zeppoles (ZAY'-puh-luhz) made by DeFusco's Bakery in Johnston.

The pastries also were sold at other stores around the state and have been recalled. The bakery has voluntarily shut down until further notice.

Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

MB - There must have been some heavy contamination in this bakery since this product is not one that would should allow for growth.



The Smokehouse LLC Recalls One Batch Of Portier Fine Foods Norwegian Smoked Salmon Because Of Possible Health Risk
FDA Release
Contact:
The Smokehouse
1-914-630-4788

FOR IMMEDIATE RELEASE - March 29, 2011 -The Smokehouse LLC of Mamaroneck, New York, is conducting a voluntary recall of PORTIER FINE FOODS Norwegian Smoked Salmon of various size packages including 4 oz., 8 oz., 16 oz. and random weight sizes, Batch Code 066 only, due to potential contamination with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

PORTIER FINE FOODS Norwegian Smoked Salmon with code 066 was distributed and sold on March 7, 2011 to retailers in NY, NJ, CT.

Batch Code 066 (represents Julian date of March 7, 2011) is located on a white label on the rear of gold boards, which are in clear, vacuum packed packages. This is the only batch code affected. The product was also labeled with an “EXPIRES ON” date of 3/21 (3/21/11). Since the product may be stored frozen, the likelihood exists that the affected code (066) may still be available in consumers’ homes.


Thomas Produce Recalls Jalapeno Peppers Because of Possible Health Risk

Thomas Produce of Boca Raton, FL, is recalling 320 boxes of Jalapeno Peppers because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Product: Jalapeno peppers from Thomas Produce
Distributed: Sold to distributors in Florida, New York, North Carolina, New Jersey, Minnesota, and Pennsylvania from 2/15/2011 to 2/18/2011.
Why: Possble Salmonella contamination
Illnesses reported: None
For more information: Contact Richard Wilson of Thomas Produce Company at 1-561-482-1111 Monday through Friday between 9 a.m. and 4:30 p.m. EST.