FDA Issues Warning Letter to NY Bakery for Rodents and Filth

FDA issued a Warning Letter to a NY Ready-to-Eat (RTE), baked goods manufacturing facility.
Due to the length of the write-up, a quick summary is here:

• No Preventive Controls Plan.
• Numerous rodents, rodent poop, and cockroaches around food and food contact packaging
• Filth was found on the packaging and on equipment
• Sanitation was inadequate for food processing equipment in terms of allergen control
• Facility had a bunch of issues - gaps in doors, poor flooring, etc
• Used color material that they should not have used
• Did not label allergen on label
• Etc

How does a facility like this operate?

WARNING LETTER
Crispy Delight Corp.
MARCS-CMS 585315 — September 06, 2019

FDA Warning Letter Issued to Processor of RTE Food

FDA Issued a Warning Letter to Flying Food Group, a group that makes RTE products for airlines.

Hazard analysis did not recognize Listeria as a hazard for exposed RTE product - ."....you did not appropriately evaluate environmental pathogens in accordance with 21 CFR § 117.130(c)(ii). You manufacture RTE foods that are exposed to the environment at several steps (e.g., meat slicing, produce cutting, batching, assemble product) where the food could be contaminated with environmental pathogens, such as L. monocytogenes, and the food does not receive a subsequent control for environmental pathogens."

Through FDA sampling, Listeria on food contact (zone 1) and adjacent areas (zone 2) -  "eleven environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Of the eleven positive swabs, five swabs were collected from food contact surface areas, and six swabs were collected from areas adjacent to food contact surface areas."

There was no preventive control for Listeria - "As evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3)."

GMP issues 

• Did not clean your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food - Exposed slices of meat were observed being stored on and in contact with the sides of a stainless-steel rack that contained visible debris.  Exposed single use food containers were observed stored inside crates that contained visible dirt and debris
• Employees were observed touching the sides of crates with visible debris without cleaning, sanitizing, or changing their gloves prior to handling bread slices used to make chicken & smoked bacon sandwiches.

Allergen not identified on Hazard Analysis even though different allergen groupings on shared equipment - You did not identify undeclared allergens and allergen cross-contact as a known or reasonably foreseeable hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment. Your hazard analysis in “FSQ 01-01, General Food Safety/HACCP Plan 080218” considers allergens as potential chemical hazards at the (b)(4) and “(b)(4)” steps, indicating that allergens do not require a preventive control.

Missing Supply Chain Preventive Control for Supplier-Washed Leafy Greens - washing of leafy vegetables and conveying leafy vegetables in water-based systems such as flumes. You have indicated that such washing/sanitizing is done by suppliers or inhouse. When done by suppliers, a supply-chain program would be required. In addition, for RTE produce that does not have a kill step, you should evaluate the need for a supply-chain program that addresses growing/harvesting by farms, which may be your suppliers or your supplier’s supplier.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flying-food-group-llc-581977-08122019
Flying Food Group, LLC 
MARCS-CMS 581977 — August 12, 2019

Florida Supermarket Closes Operations as State Finds Listeria Throughout Operation

A Florida grocery store closed its business after a reinspection by the State of Florida found Listeria throughout the operation.

"Samples collected on Sept. 9 found evidence of listeria bacteria on various surfaces around the store, leading inspectors to issue 15 stop-sale and stop-use orders. Inspectors last tested food samples from the Margate store on Aug. 6. Six samples were collected and no listeria was found. No illnesses have been reported."

Before it shut down, the store tried to sell of its product at fire sale prices.  Unfortunately, this included product that may have been subject to Listeria contamination.  This caused the State to issue an order to cease all operations.  Some of this product came from quarantined area.

It is a rare occurrence where a retail store is shut down by the State due to Listeria positive samples...it is also rare that a state department monitors Listeria in a retail operation to begin with.  In this case, the initial sampling occurred in the first quarter of the year with Listeria being found.  The retail established dumped product and resumed operations.  In September, the store was respected and Listeria was found again.  Easy to guess that if the State had sampled a month after the initial sampling, they would have found it.

South Florida Sun Sentinel
https://www.sun-sentinel.com/business/fl-bz-penn-dutch-immediate-shut-down-20190919-itojdrhlpndtni7xs2366k2bwi-story.html
State shuts down Penn Dutch in Margate for ‘endangering public health’ over listeria
By Doreen Christensen
South Florida Sun Sentinel |
Sep 19, 2019 | 8:22 PM

CDC Report - Surveillance for Foodborne Disease Outbreaks United States, 2017 Annual Report

CDC issued report of foodborne illness in the U.S. -  Surveillance for Foodborne Disease Outbreaks United States, 2017 Annual Report.
 Highlights

• In 2017, 841 foodborne disease outbreaks were reported, resulting in 14,481 illnesses, 827 hospitalizations, 20 deaths, and 14 food product recalls.
• Norovirus was the most common cause of confirmed, single-etiology outbreaks, accounting for 140 (35%) outbreaks and 4,092 (46%) illnesses. Salmonella was the next most common cause, accounting for 113 (29%) outbreaks and 3,007 (34%) illnesses, followed by Shiga toxin-producing Escherichia coli, which caused 19 (5%) outbreaks and 513 (6%) illnesses, and Clostridium perfringens, which caused 19 (5%) outbreaks and 478 (5%) illnesses.
• Mollusks (41 outbreaks), fish (37), and chicken (23) were the most common single food categories implicated. The most outbreak associated illnesses were from turkey (609 illnesses), fruits (521), and chicken (487).
• As reported in previous years, restaurants (489 outbreaks, 64% of outbreaks for which a single location of preparation was  reported), specifically restaurants with sit-down dining (366, 48%), were the most commonly reported locations of food preparation associated with outbreaks.

Quality Control Office Pleads Guilty to Falsification of Records, Awaits Sentencing

A 60 year old woman, acting as a meat company's quality control officer, is now facing up to 5 years in prison for assisting the company's owner in falsifying E. coli test results.  The  owner of New England Meat Company agreed to a plea deal in August where he admitted that the test results were fake.

http://www.courant.com/breaking-news/hc-br-stafford-springs-guilty-fake-e-coli-tests-20190923-h7o7nmqnmvbftfdcid3j7stf4a-story.html
Stafford Springs meat packing plant employee pleads guilty to faking E. coli test results
By Zach Murdock
Hartford Courant |
Sep 23, 2019 | 5:14 PM

Caviar Recalled Due to Processing Error That Could Lead to C. botulinum Growth

Roland Foods, LLC of New York, New York is initiating a voluntary recall of its red and black lumpfish caviar products, which were manufactured at Ora ehf in Iceland, because they have the potential to be contaminated with Clostridium botulinum.  The potential for contamination was noted after routine testing found that the product experienced a processing issue.  Production and distribution of the product has been suspended as FDA and the company continue their investigation as to the source of the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/roland-foods-llc-initiates-voluntary-recall-roland-red-lumpfish-caviar-and-roland-black-lumpfish
Roland Foods, LLC Initiates a Voluntary Recall of Roland Red Lumpfish Caviar and Roland Black Lumpfish Caviar Due to Possible Health Risk
Summary
Company Announcement Date: September 20, 2019 

FDA Publish Date:September 20, 2019 

Product Type:Food & Beverages 

Reason for Announcement:  Potential to be contaminated with Clostridium botulinum
Company Name:Roland Foods, LLC 

Brand Name: Roland
Product Description:  Red Lumpfish Caviar and Black Lumpfish Caviar

CDC Report - 2017 E. coli Outbreak Associated with Soy Nut Butter

 CDC released a report detailing the 2017 E. coli outbreak of E. coli O157 linked to soynut butter that resulted in 32 cases from 12 states with twenty-six (81%) cases occurred in children ( <18 years old) and with 8 of those children developing hemolytic uremic syndrome (impacting kidney function).

The facility had multiple issues as was detailed in the FDA 483 report. although the ultimate ingredient source was not identified.

Items of note from the report:

• The was the first time a peanut butter alternative such as soy nut butter has been implicated as the source of an outbreak of STEC infections in the United States
• More than one-quarter of the case patients developed HUS, and all but 1 were children <18 years old.  
• CDC identified a subcluster in an Oregon child care center where secondary transmission might have contributed to the spread of the outbreak -this serves as a reminder to child care providers of the importance of appropriate hand-washing and hygiene practices to prevent the spread of infections in these settings and that children with STEC O157 infection should be excluded from attending child care centers until 2 stool cultures (obtained at least 48 hours after antimicrobial therapy, if given, has been discontinued) have negative results for STEC.
• This outbreak serves as a reminder of the important role manufacturers play in preventing foodborne outbreaks and the role brand owners have in overseeing their product safety. Soy nut butter is a ready-to-eat food with a long shelf life, and multiple foodborne outbreaks have been identified over the past few years linked to other ready-to-eat, long-shelf-life foods, such as a powdered meal replacement product, sprouted nut butters, and chia powder.
• Product contamination may have occurred through use of a contaminated ingredient or cross-contamination from contact with contaminated equipment or surfaces during manufacturing. However, because ingredient sample results were negative and multiple objectionable conditions were identified during the facility’s inspection, it was not possible to determine which specific route led to product contamination.

https://pediatrics.aappublications.org/content/early/2019/09/12/peds.2018-3978
A Multistate Outbreak of E Coli O157:H7 Infections Linked to Soy Nut Butter

This Week in Allergen Related Recalls for Week Ending September 21, 2019

Chicken Meal With Soy Ingredient Labeled as Beef Meal Astrochef LLC., a Rockwall, Texas establishment, is recalling approximately 11,475 pounds of frozen chicken pub style entrees labeled as beef pub style entrees due to misbranding and undeclared allergens, the product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered when Conagra Brands received consumer complaints reporting that the product was incorrectly labeled.

Cake Item with Egg Mislabeled as Lemon Dessert Bars with No Egg - .Schwartz Brothers Bakery of Seattle, WA is recalling 24 units of Lemon Dessert Bars, sell by date 09/21/19, because it may contain undeclared Egg.  The recall was initiated after it was discovered that some of the Lemon Pound Cake, which contain Egg, was mislabeled as Lemon Dessert Bars. The Lemon Dessert Bars label does not declare Egg.

Wrong Product Labeled as Gluten Free Product - Perdue Foods, LLC, a Perry, Ga. establishment, is recalling approximately 495 pounds of frozen ready-to-eat chicken products due to misbranding and undeclared allergens, the product contains wheat, a known allergen, which is not declared on the product label. The frozen ready-to-eat chicken products are labeled as gluten free chicken breast tenders but contain chicken nugget products. The problem was discovered when the company notified FSIS that they received two consumer complaints regarding the mislabeled product.

Peanut Butter Cookies Do Contain Peanut - Southeastern Grocers (SEG), the parent company of BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie stores, is issuing a voluntary recall for two 18-count cookie products sold in the bakery due to the inclusion of an undeclared allergen in the products.  The 18-count Variety Pack containing Peanut Butter Cookies and the 18-count Peanut Butter Cookie did not include peanut ingredients on the label.

Bags of Flour Recalled After Sample Test Positive for E. coli

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020. The recall is being issued for the potential presence of E. coli O26 which was discovered during sampling of the five-pound bag product.  No illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/general-mills-recalls-five-pound-bags-gold-medal-unbleached-all-purpose-flour
General Mills Recalls Five Pound Bags of Gold Medal Unbleached All Purpose Flour

Summary
Company Announcement Date:  September 16, 2019
FDA Publish Date:  September 16, 2019
Product Type:  Food & Beverages
Reason for Announcement:  E. coli O26
Company Name:  General Mills
Brand Name:  Gold Medal
Product Description:  Unbleached All Purpose Flour