CA Sprout Operation Cited for Lack of Listeria Control

The FDA inspected a sprout growing, harvesting, packing, and distributing facility, located in Sacramento, California.  FDA issued a Warning Letter with the following identified issues:

• Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in the growing, harvesting, packing, and holding environment 
• FDA "identified Listeria seeligeri in 1 of 102 environmental swabs (INV1177912, Sub 28). Sub 28 was collected from a joint surface between your metal sprout wash tank and metal exterior surface within your sprout growing room"
• Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 
• Did not appropriately clean and sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR
• Had inadequate sanitation practices and use of a sanitizing agent in place of conducting cleaning activities
• Personnel at the firm did not use hygienic practices 
• Did not appropriately train personnel who handle (contact) covered produce or food contact surfaces, and personnel who conduct covered activities,

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022
Sun Sen Co., Inc.

FDA Issues Warning Letter to RTE Produce Processor With Positive Listeria Environmental Samples

FDA issued a Warning Letter after inspection and environmental sampling of  a ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility located in Wakefield, MA.  This "facility receives fruit and vegetables, some of which are RTE, including cantaloupe and apples, that are processed into RTE sliced, diced, and/or cubed fruit and vegetable products (e.g., cubed cantaloupe and sliced apples). The RTE fruit and vegetable products are exposed to the environment prior to packaging, where they may become contaminated with environmental pathogens such as L. monocytogenes. As evidenced by the findings of L. monocytogenes in your production environment and current inspectional findings, you did not identify and implement sanitation controls 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" 

"FDA laboratory analysis of the environmental sample 1119291 collected on February 8, 2022, from various areas in your processing facility confirmed eight (8) of fifty-six (56) environmental swabs were positive for L. monocytogenes. Of the positive findings, three (3) swabs were collected from food-contact surfaces where RTE cantaloupe and RTE sliced apples were being prepared, including:

• Surface of the stainless-steel fruit table used for coring apples
• Blade of the yellow knife used to cut cantaloupe
• Green squeegee used for wiping the surface of the stainless-steel table where cantaloupes were being processed
• In addition, L. monocytogenes was found on a tote used for holding bulk/whole cantaloupe.

GMP issues identified during the  inspection: 

• Investigators observed employee handling practices which could lead to cross-contamination of food-contact surfaces and RTE food products including "an employee used a high-pressure hose that had contacted the floor before use and sprayed the rear wall of the main production facility during production of RTE romaine lettuce. The spray from the hose was observed contacting the floor several times and creating an aerosol and mist within the production area that was also visible in the air several feet away from the RTE romaine that was processed."
• Condensate was observed dripping from the overhead ceiling and refrigeration unit in the main production room to the floor, approximately 10 feet from where RTE diced red onion was being processed. We have previously notified you of our concerns related to condensate during FDA inspections conducted in 2018 and 2019.
• The plastic conveyer belt used for production of r butternut squash product was damaged, with rough surfaces and missing teeth.
• Several areas of flooring and surfaces around drains in the main production area were damaged, with exposed rough aggregate.
• Plastic bins/barrels used to hold RTE finished products, vegetable and fruit waste, and garbage were damaged, cracked, and chipped, with rough surfaces.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banks-square-market-corp-dba-produce-connection-631118-09022022

Banks Square Market Corp. dba The Produce Connection

MARCS-CMS 631118 — SEPTEMBER 02, 2022

Kansas Feed Mill Cited for Preventive Controls Violations in Response to Copper Toxicity Issue

FDA issued a Warning Letter to a KS feed processor after inspected by Kansas Dept of Ag.  The "KDA inspections were conducted in response to consumer complaints regarding suspected copper poisoning from sheep food that resulted in multiple sheep deaths. A sample of your “Lamb Builder 16% Lamb Creep 80869” sheep food collected by KDA on November 19, 2021 and analyzed by the Nebraska Department of Agriculture contained an elevated level of copper at 31.0 parts per million (ppm), which is a level that would cause acute toxicity in sheep.1 The recognized maximum tolerable level of copper in food for sheep is 15 ppm on a dry matter basis, assuming normal concentrations of molybdenum and sulfur".

FDA stated, "Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).  Specifically, your reliance on your prerequisite program failed to reduce the probability that an elevated level of copper will occur in your animal food in the absence of a preventive control."

FDA had issue with mycotoxin control of incoming ingredients as well as those that may form during storage.

• The "company did not identify the known or reasonably foreseeable hazards of fumonisin and deoxynivalenol (DON or vomitoxin) for all grains and their co-products you receive and use as ingredients at your facility that are susceptible to fumonisin and vomitoxin. Also, you did not evaluate the severity of the illness or injury if the hazards were to occur, or the probability that the hazards would occur in the absence of preventive controls, to determine whether the hazards require a preventive control.  Furthermore, your “Aflatoxin Testing Procedure” only includes steps for sampling and testing of corn and does not include steps for other grains and grain co- products you receive, store, and use as ingredients at your facility."

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

CT Ice Cream Company Issued A Warning Letter for Lack of Listeria Control

FDA issued a Warning Letter to Royal Ice Cream Company of  Manchester, CT 06040-6534.  FDA 
determined that the RTE ice cream products manufactured by this facility are 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 they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.

FDA state that the company had multiple and repeat findings of L. monocytogenes in the production environment, and thus, the company did not identify and implement preventive controls adequate to ensure that they were significantly minimizing or preventing the hazard of the environmental pathogen L. monocytogenes.  

The company had issued a recall of ice cream after FDA sampling had found positive samples.  This recall was in February, 2022.

"FDA’s inspection included the collection of environmental swabs on January 19, 2022, during production and found that two (2) of seventy-eight (78) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a filler head where RTE ice cream was being dispensed into pint-sized finished packages and one (1) swab was collected from the stainless-steel table where RTE ice cream sandwiches were being prepared. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in three (3) environmental swabs, including two (2) from areas adjacent to food-contact surfaces. Furthermore, in response to our 2022 environmental sample findings and your voluntary recall initiated in February 2022, the Massachusetts Department of Public Health (MDPH) collected retail finished product samples which confirmed L. monocytogenes in one (1) finished product sample of salted caramel ice cream."

These same strains were found to have been present in the facility in past sampling.  "The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2017. We first advised you of the importance of these WGS results on March 4, 2022, and subsequently provided updates to the WGS analysis on the following dates: March 17, 2022, April 7, 2022, and June 30, 2022."

FDA stated that the "hazard analysis did not identify pathogens at your processing step of “(b)(4)” as requiring a preventive control because “Pathogens are unlikely to grow in the low temperature present in the freezer.” However, during the inspection, employees were observed transferring an RTE cookie dough sandwich sheet to the (b)(4), where the ice cream sheet was cut into 4 oz. bars and was exposed to the environment prior to packaging. L. monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE ice cream products, exposed to the environment at steps such as (b)(4), and L. monocytogenes does not require growth to present a hazard."

FDA found a number of issues during inspection that included employees touching non-contact surfaces and then touching food, improper high pressure house use (employees were observed using a high-pressure hose to rinse a stainless-steel pail and to spray the processing room floor, and overspray was aerosolizing immediately adjacent to uncovered flavor vats containing RTE (b)(4), uncovered RTE ingredients on the production table, and near the food-contact surfaces of the filler in the ice cream production area. FDA collected environmental sample (b)(4), swab (b)(4), from head of this filler and detected L. monocytogenes.), 

They had issues with their environmental monitoring system - "did not collect your environmental swabs at the frequency identified within your “Environmental Monitoring Procedures”" and the " environmental monitoring procedure did not identify the locations from which samples will be collected."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-ice-cream-company-inc-630433-07282022
The Royal Ice Cream Company Inc.

MARCS-CMS 630433 — JULY 28, 2022

TX Establishment Recalls Chicken Bowls Labeled as Beef Bowls Creating Allergen Mislabeling

Valley International Cold Storage Acquisition, LLC, a Harlingen, Texas establishment, is recalling approximately 22,061 pounds of frozen beef products due to misbranding and undeclared allergens, the product contains milk, a known allergen, which is not declared on the product label.  The problem was discovered when the producing establishment notified FSIS that it had received consumer complaints that the Korean-Style Beef cartons contained a chicken-based product.

Valley International Cold Storage is a repack facility.  A reminder of the importance of controls for those operations that are repacking product where there may not be visible product to check, but rather a matching of product code to outside packaging.

https://www.fsis.usda.gov/recalls-alerts/valley-international-cold-storage-acquisition-llc-recalls-frozen-beef-products-due
Valley International Cold Storage Acquisition, LLC, Recalls Frozen Beef Products Due To Misbranding And Undeclared Allergens
VICS ACQUISITION, LLC

USDA Issues Health Alert for Chicken Product Due to Undeclared Allergens After Back Label Error

USDA-FSIS is issuing a public health alert due to concerns that the raw, ready-to-cook chicken entrée products may contain egg, a known allergen, which is not declared on the finished product label. "The problem was discovered when the establishment notified FSIS that they received notification from their customer that an incorrect label was on the back of the plastic wrapped metal container. The label on the back of the product contains information related to a chicken cordon bleu product, which does not contain egg. The bacon cheddar chicken product contains egg."

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-chicken-entree-products-due-misbranding-and
FSIS Issues Public Health Alert For Chicken Entree Products Due To Misbranding And An Undeclared Allergen
TAMPA BAY FISHERIES

Expanded Recall for Family Dollar and Their Distribution System - Storing Product Outside of Temperature Requirements

Family Dollar expanded a July 21, 2022 recall for certain FDA regulated products that were stored outside of the required temperature. "This notice covers the recall of Over-the-Counter Medical Devices. An earlier notice issued July 21, 2022 covered a related recall of Over-the-Counter Pharmaceutical Products."

As you may recall, In February of this year, Family Dollar also had a massive recall of products handled by their Arkansas distribution center that had a heavy rat infestation.

Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements
Summary
Company Announcement Date:  August 05, 2022
FDA Publish Date:  September 16, 2022
Product Type:  Medical Devices
Reason for Announcement:  Product was stored outside of labeled temperature requirements.
Company Name:  Family Dollar
Brand Name:  Multiple brand names
Product Description:  Various OTC medical products

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.