Friday, April 22, 2022

FL Produce Company Recalls Bagged Organic Green Beans After Their Testing Finds Listeria in Sample

Alpine Fresh, Inc. of Doral, Florida is voluntarily recalling its 1 pound packages of "Hippie Organics" French Beans from lot# 313-626, because they have the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing by the company revealed the presence of Listeria monocytogenes in 1 pound packages of "Hippie Organics French Beans From lot # 313-626."  The problem has been found to be isolated to the identified lot and the company has taken corrective actions to prevent a recurrence.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alpine-fresh-conducts-voluntary-recall-hippie-organics-french-beans-because-possible-health-risk
Alpine Fresh Conducts Voluntary Recall of “Hippie Organics French Beans” Because of Possible Health Risk
Summary
Company Announcement Date:  April 21, 2022
FDA Publish Date:  April 21, 2022
Product Type:  Food & Beverages  Organic Food / Home Grown
Reason for Announcement:  Listeria monocytogenes contamination
Company Name:  Alpine Fresh, Inc.
Brand Name:  Hippie Organics
Product Description:  French Beans

PA Dairy Recalls Small Amount of Chocolate Marshmallow Ice Cream Filled with Chocolate Peanut Butter Ice Cream

Turkey Hill Dairy of Conestoga, Pa., is recalling select 48 oz containers of its Chocolate Marshmallow Premium Ice Cream because the product may contain undeclared peanuts. The recalled products are limited to 385 containers of the following product and may have been purchased by consumers between 4/14/2022 and 4/19/2022:  The recall was initiated after it was discovered by a consumer who contacted Turkey Hill that select containers of Chocolate Marshmallow Premium Ice Cream may have been inadvertently filled with Chocolate Peanut Butter Cup Ice Cream during production

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/turkey-hill-dairy-issues-voluntary-recall-and-allergy-alert-undeclared-peanut-select-chocolate
Turkey Hill Dairy Issues Voluntary Recall and Allergy Alert for Undeclared Peanut in Select Chocolate Marshmallow Premium Ice Cream Containers
Summary
Company Announcement Date:  April 21, 2022
FDA Publish Date:  April 21, 2022
Product Type:  Food & Beverages  Ice Cream/Frozen Dairy
Reason for Announcement:  Undeclared peanuts
Company Name:  Turkey Hill Dairy
Brand Name:  Turkey Hill
Product Description:  Chocolate Marshmallow Premium Ice Cream

Still More Imported Enoki Mushrooms Recalled for Listeria

T Fresh Company of City of Industry, CA is recalling its 7.5oz (200g) enoki mushrooms, Lot #6021053 grown in China, because it has the potential to be contaminated with listeria monocytogenes.  Lot #6021053 was distributed from California and Texas to retail stores through produce distributors. The potential for contamination was noted after surveillance sampling by the CDPH revealed the presence of Listeria monocytogenes in 7.05oz (200g) packages of enoki mushroom. Product is packaged in a Light Blue & transparent plastic packaging, with " Yes" Logo for the 200g(7.5oz). 
Are imported enoki mushrooms a risk for Listeria...Yes!

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/t-fresh-company-city-industry-ca-recalling-its-75oz-200g-yes-enoki-mushrooms-due-possible-health
T Fresh Company of City of Industry, CA is Recalling its 7.5oz (200g) Yes! Enoki Mushrooms Due to Possible Health Risk
Summary
Company Announcement Date:  April 20, 2022
FDA Publish Date:  April 21, 2022
Product Type:  Food & Beverages  Produce
Reason for Announcement:  Listeria monocytogenes contamination
Company Name:  T Fresh Company
Brand Name:  Yes!
Product Description:  Enoki Mushrooms

CA Produce Distributor Recalls Organic Zucchini After FDA Sampling Detects Salmonella

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling case lot #38706503 of Organic Zucchini, because it has the potential to be contaminated with Salmonella.  This recall was initiated because a single lot of imported organic zucchini tested positive for salmonella as a result of a routine FDA sampling.  No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-variety-produce-inc-voluntarily-recalls-organic-zucchini-because-possible-health-risk
World Variety Produce, Inc. Voluntarily Recalls Organic Zucchini Because of Possible Health Risk
Summary
Company Announcement Date:  April 19, 2022
FDA Publish Date:  April 19, 2022
Product Type:  Food & Beverages  Organic Food / Home Grown
Reason for Announcement: Salmonella
Company Name: World Variety Produce, Inc.
Brand Name:  Organic Marketside
Product Description:  Organic Zucchini

Wednesday, April 20, 2022

Louisiana Bakery Issued a Warning Letter for Inadequate Allergen Controls

FDA issued a Warning Letter to Langlinais’ Baking Company, a ready-to-eat (RTE) bakery located in Lafayette, LA.  The issues found were that the company did not have allergen controls in place and did not recognize Salmonella as an issue for the RTE bakery.

The "hazard analysis did not identify and evaluate the hazard of undeclared allergens due to incorrect labeling at the packaging step to determine whether it is a hazard requiring a preventive control. [The] facility manufactures and labels products which contain wheat (e.g., French Bread and Hot Dog Buns) as well as a product which contains both wheat and milk (Sweet Roll Hamburger Buns)."  The firm "did not have such controls in place as evidenced by [the] November 2021 recall of French Bread manufactured on November 1, due to undeclared wheat. Also, during the inspection [the firm] stated that in October 2021 you manufactured the same French Bread with the same label (not declaring wheat) and distributed it to the same customer. Further, we note that your written prerequisite “Allergen Control Program” does not include monitoring, corrective action, or verification procedures to ensure control of undeclared allergens."

The firm 'did not identify and evaluate the hazard of allergen cross-contact to determine whether it is a hazard requiring a preventive control at the dough mixing and forming steps. [The firm] use butter, which contains milk, to manufacture Sweet Roll Hamburger Buns on mixing and forming equipment shared with products that do not contain this allergen (e.g., French Bread and Hot Dog Buns) on the same day. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls. Therefore, undeclared allergens due to incorrect labeling is a known or reasonably foreseeable hazard at the packaging step. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control."

The "hazard analysis did not evaluate environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control at the cooling and packaging steps, to comply with 21 CFR 117.130(c)(1)(ii). Your facility manufactures RTE bread and roll products which are exposed to the environment after being baked and until they are packaged."

The firm did " not clean and sanitize equipment in a manner that protects against allergen cross-contact and against contamination of food and food-contact surfaces, as required by 21 CFR 117.35(a). On November 2, 2021, after a “(b)(4) clean” was conducted following production of Sweet Roll Hamburger Buns, FDA investigators observed two whole loaves of French Bread wedged between food-contact rollers on an overhead conveyor belt. FDA investigators also observed food residue on Mixer (b)(4) and on the (b)(4) dough forming equipment. This equipment is shared between Sweet Roll Hamburger Buns (which contain milk) and products which do not contain milk. Your sanitation manager had checked the equipment in this room and indicated it was “Go” on the “Post Cleaning Inspection” form."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/langlinais-baking-company-625493-03142022
WARNING LETTER
Langlinais’ Baking Company
MARCS-CMS 625493 — MARCH 14, 2022

FDA Issues Warning Letters to Two NY Importers for Not Having FSVP for Imported Food Items

FDA issued Warning Letters to two NY based importers for not having FSVP in place for the items that they import.  While they had some records required by the FSVP, these firms did not meet the requirements of FSVP.

Eli’s Manhattan Warehouse, Inc. of New York, NY did not develop, maintain, and follow an FSVP for any of the foods you import, including each the following food products: Blueberry, strawberry, cherry jams from (b)(4) located in (b)(4) Olive oil from (b)(4) located in (b)(4) Honey from (b)(4) located in (b)(4)

Agroson’s LLC, of, Bronx, NY 10474-6115 did not develop an FSVP for the following food products you import: Limes imported from (b)(4)

FDA Warning Letter Issued to Pet Food Facility for Inadequate Salmonella and Mycotoxin Controls

A pet food manufacturing facility was issued a Warning Letter by FDA for failure to adequately control two hazards associated with pet food...Salmonella and Mycotoxins.  FDA issued the Warning Letter after a series of 5 recalls associated these hazards as well as an FDA inspection.  FDA stated that the although the firm conducted "voluntary recalls to remove adulterated product from the marketplace", "recalling product does not prevent the reoccurrence of a hazard in your pet food. Recalling product is a reaction to an animal food safety system failure that has occurred. It is [the company's] responsibility to implement a robust hazard analysis and risk-based preventive controls program to prevent product adulterated with mycotoxin or Salmonella from entering the food supply."

Some of the issues cited:
  • The "firm’s laboratory tested a sample of finished dog food kibble, Evolve Chicken and Rice Dog Formula (b)(4), and detected an elevated aflatoxin level of 32.7 ppb. This is an indication that [the company] failed to implement your ingredient testing preventive control Despite this, [the company] did not hold the out-of-specification dog food for determination of disposition, as required by [the] corrective actions in [the] food safety plan and SOPs. [The plan states] that any product that is determined to fall outside of [the] specifications should be placed on hold."
  • The "firm failed to implement your preventive control when [the company] failed to follow the manufacturer’s mycotoxin test kit instructions, as well as [the] firm’s (b)(4) regarding sample preparation for incoming grain analysis." 
  • "The Minnesota Department of Agriculture collected a routine surveillance sample of [the comany's] pet food “Sprout Sporting Dog Food” from retail and laboratory analysis detected Salmonella Johannesburg in the sample, resulting in a Class I recall described above."
  • FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in [the] post lethal treatment shaker screen room between Shaker Screen D and Shaker Screen E. {The] firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle."
FDA was requesting to meet and discuss what the firm's path moving forward.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-618141-03072022
WARNING LETTER

Sunshine Mills, Inc

MARCS-CMS 618141 — MARCH 07, 2022

Monday, April 18, 2022

FDA Issues Warning Letter to Seafood Processor For Conditions that Led to Salmonella Outbreak

FDA issued a Warning Letter to a seafood processor located in Denver Colorado.  This inspection was 
"initiated as part of a multistate foodborne outbreak investigation of Salmonella Thompson (S. Thompson) illnesses linked to seafood." According to the CDC, 116 people from 14 states were infected with the outbreak strain of S. Thompson. On October 8, 2021, your firm recalled certain types of fresh seafood processed at your facility and distributed from May 2021 to October 7, 2021, because they had the potential of being contaminated with Salmonella."

"FDA laboratory analyses found the presence of the outbreak strain of S. Thompson, a human pathogen, in [the] facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule)."

"Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption."

The facility had numerous issues relating to process control and sanitation.

FDA Warning Letter
Northeast Seafood Products, Inc. - 621620 - 03/24/2022 | FDA
Northeast Seafood Products, Inc.
MARCS-CMS 621620 — MARCH 24, 2022

FDA Issues Warning Letter to MD facility for Deviations from LACF Regulations

FDA issued a Warning Letter to a Maryland low acid canning facility for issues associated with the Low Acid Canned Food Regulation (LACF).  The deviations cited were focused on failures to ensure double seam integrity and failure to ensure  that the proper critical factors were maintained as part of the canning process specifically maintaining specified headspace.

The Low Acid Canned Food regulations require that the canning process, including proper filling, sealing and thermal process, are established and followed.  In sealing, there are specific parameters that must be continuously met to ensure integrity of the can.  The seal of the can, called a double seam, must be measured at regular intervals through several measurements, some of which require that the seam is taken apart as part of a tear-down procedure.  When tolerances around these measurements are not met, corrective action is required.

This company had numerous issues ranging from not doing the required amount of measurements, to out of spec measurements, to inadequate corrective action.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/treehouse-foods-inc-620320-01282022
WARNING LETTER
TreeHouse Foods, Inc.
MARCS-CMS 620320 — JANUARY 28, 2022