Penn State Food Safety Blog

SEPTEMBER 25, 2024

FDA issued a Warning Letter to St. Louis Calco, a sprout operation located in Fenton, MO. Fenton, MO 63026-4323 United States Issuing Office: Division of Human and Animal Food Operations West II United States WARNING LETTER March 21, 2024 CMS Case# 669917 Dear Mr. Zhou: The U.S. monocytogenes). monocytogenes.

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Penn State Food Safety Blog

AUGUST 30, 2024

FDA issued a Warning Letter to a small sprout farm operation located in Pennsylvania. The facility operates as a qualified facility under modified requirements. The company told our investigator that this gray sludge was food-grade oil. This may cause the floor to be a harborage site for pathogens. Pei, The U.S.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Barsotti Juice Company, Inc. Findings: "HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4).

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Penn State Food Safety Blog

JULY 1, 2024

FDA issued a Warning Letter to Dollar Tree retailer for failing to stop selling the lead-contaminated cinnamon apple sauce after the recall was announced by WanaBana. From the Warning Letter, "On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches.

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Penn State Food Safety Blog

JULY 23, 2024

FDA issued a Warning Letter to Discover Fresh Foods, LLC of Greenville, SC, a manufacturer of refrigerated ready-to-eat (RTE) dips and spreads. FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for Listeria innocua (L. USDA FSIS notified FDA L. monocytogenes.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a California seafood processor who makes ready-to-eat (RTE) salmon and tuna. As part of the inspection, FDA conducted sampling and analysis of the environmental samples (1195789 and 1239088) confirmed that thirty-four (34) of one hundred (100) environmental swabs were positive for pathogenic L.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

In June of 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected Iowa Egg Company Inc.'s FDA cited a number of issues where the company was not meeting the requirements. MARCS-CMS 663904 — DECEMBER 15, 2023 Recipient: Danny Dang Director/Owner Iowa Egg Company Inc.

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Penn State Food Safety Blog

APRIL 26, 2024

FDA issued a Warning Letter to Appleton City Feed Service LLC of Appleton City, MO for violations to Preventive Controls for Animal Feeds regulations as well as the Veterinary Feed Directive (VFD). link] Appleton City Feed Service LLC MARCS-CMS 662279 — NOVEMBER 01, 2023 Recipient: Ms. Smith Owner Appleton City Feed Service LLC 302 W.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

FDA issued a Warning Letter to a CA company selling goat milk for toddlers. According to the Warning Letter the product, Sammy’s Milk, is considered an infant formula under section 201(z) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § link] Graceleigh, Inc. Hendricks: The U.S. Moms like you do too.”

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Penn State Food Safety Blog

AUGUST 15, 2024

FDA issued a Warning Letter to High Quality Organics, a ready-to-eat (RTE) spice facility, located in Reno, NV. Reno, NV, from November 27 through December 07, 2023, and January 03 through January 04, 2024. Reno, NV, from November 27 through December 07, 2023, and January 03 through January 04, 2024. As examples: a.

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Penn State Food Safety Blog

OCTOBER 27, 2023

FDA issued a Warning Letter after an investigation "conducted as a follow-up to a Reportable Food Registry (RFR) report regarding suspected monensin poisoning from a medicated feed that resulted in numerous cattle deaths". MARCS-CMS 653966 — AUGUST 21, 2023. Recipient: Dr. Michael P.

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Penn State Food Safety Blog

AUGUST 4, 2023

FDA issued a Warning Letter to a pretty small NJ Italian Food company who did not have a Food Safety Plan. There continues to be issues involving small food companies that have yet to address FSMA regulations. Looks to be a retail operation that is doing distribution. link] Porfirios Italian Foods, Inc.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to JX Restaurants, Inc located in Maryland Heights, MO a manufacturer of ready-to-eat (RTE) rice and noodle-based meals and RTE rice and noodle-based under USDA jurisdiction. And as proof to this point, FDA conducted swabbing and found Listiera. FDA also collected environmental samples (i.e.,

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Penn State Food Safety Blog

DECEMBER 13, 2023

While FDA cited the company for issues with its Preventive Controls Plan, FDA also hi on the company for failing to report the non-compliant product into the Reportable Food Registry. The Registry helps the FDA better protect the public health by tracking patterns and targeting inspections." Deverell, The U.S.

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Food Safety News

JANUARY 11, 2024

The reorganization of the Food and Drug Administration’s human foods program began in 2023 with the appointment of Jim Jones to be the agency’s first-ever deputy commissioner for human foods. He says that will strengthen the FDA’s field-based oversight program.

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Penn State Food Safety Blog

APRIL 26, 2024

FDA issued a Warning Letter to Euro USA Inc seafood processing facility in Cleveland Ohio. O’Donnell: The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4481 Johnston Parkway, Cleveland Ohio from July 10 to July 25, 2023.

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Penn State Food Safety Blog

JULY 12, 2024

FDA issued a Warning Letter to PepsiCo for their Quaker Oats manufacturing facility located in Danville, IL, a facility that manufactures RTE granola bars and RTE cereals. This facility issued a recall of product for Salmonella in December of 2023. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Gilster-Mary Lee Corporation of Chester, IL after they determined that the company's recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 WARNING LETTER [link] Gilster-Mary Lee Corporation MARCS-CMS 658271 — AUGUST 28, 2023 Recipient: Mr. Thomas B.

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Penn State Food Safety Blog

MARCH 27, 2024

FDA issued a Warning Letter to F1 Foods Inc, of Bridgewater, MA, a processor of ready-to-eat (RTE) prepared foods, including the processing of seafood and acidified food products. It seems this facility was operating as if not regulations exist. They even do consulting on HACCP?? They even do consulting on HACCP??[link]

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Penn State Food Safety Blog

JUNE 12, 2024

FDA issued a Warning Letter to Midwest Foods, LLC, of Ankeny, IA. Failed to file scheduled process to FDA for some of the acidified foods Failed to follow scheduled process for some acidified products. Ste 113, Ankeny, IA 50023-1802, on December 11-13, 2023. Ankeny Blvd., product sizes.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Woody’s Pet Food Deli of West Saint Paul, MN., a processor of raw pet food products. The firm uses an acetic acid, PAA, and hydrogen peroxide (b)(4), as the method to eliminate pathogens from the raw pet food products. Palma Owner Agila Corporation dba Woody’s Pet Food Deli 105 W.

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Penn State Food Safety Blog

NOVEMBER 8, 2023

FDA issued a Warning Letter to ADM Animal Nutrition and their vitamin and mineral premix and preblend animal food manufacturing facility, located in Effingham, Illinois. 2 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.3

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Penn State Food Safety Blog

DECEMBER 27, 2023

FDA issued a Warning Letter to US Gulf Coast Trading Co, a refrigerated, frozen, and ambient food product warehouse located at in Houston, TX. These conditions could allow for the entrance of pests into the facility, which may cause contamination of food products stored inside the warehouse. 14100 Auto Park Way Ste.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a California bread company after the company had a recall for undeclared allergens. In the inspection, FDA found inadequate allergen controls. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No. the listing regulation for FD&C Yellow No.

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Penn State Food Safety Blog

DECEMBER 27, 2023

In a Warning Letter issued by FDA to a small KY desert company, Deserts by Hellen, FDA identified numerous GMP issues that demonstrate a lack of proper sanitary controls. MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A. Specifically, the following employee practices were noted on February 28, 2023: a.

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Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a California Bakery. To make the long notice short [I really don't want to type this one out], the firm operated as if they had no knowledge of regulations. There was no food safety plan, and with that, no controls for allergens, environmental pathogens, etc. You do not have this program in place.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

FDA inspected a bottled water manufacturing facility located in Hilo, HI and issued a Warning Letter to that firm. You may find the Act and FDA’s regulations through links on FDA’s Internet homepage at www.fda.gov. We received responses to the FDA-483 on March 14, 2024 and March 29, 2024.

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Penn State Food Safety Blog

APRIL 3, 2024

The internet has opened the door to many food operations to sell products. Recently, FDA inspected a Berkley California operation, Living Tree Community Foods, Inc. link] and found that they were not producing foods to the required food safety standards. But is that enough?

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Penn State Food Safety Blog

DECEMBER 27, 2023

FDA issued a Warning Letter to a NY Cheese processor. During a June 2023 inspection of the facility, FDA found Listeria in the facility as well as identified many GMP issues related to cleaning and poor equipment. Thereafter on July 18, 2023, the same residues were observed on these tables. monocytogenes." monocytogenes."

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Penn State Food Safety Blog

JULY 1, 2024

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)

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Penn State Food Safety Blog

FEBRUARY 14, 2024

FDA issued a Warning Letter to Lucky K.T. Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product. It is a huge Warning Letter, so in quick summary: Did not have a food safety plan with the required elements for any of the products manufactured at the facility. o FDA sample of Lucky K.T.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a Colorado based RTE noodle company for not have a food safety plan in place, and with that any of the controls needed as part of that plan. 350d], and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR § 1.225 -1.245].

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

FDA issued a Warning Letter to Brewing Market Coffee, an acidified manufacturing facility located in Boulder, Colorado. The company "failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6,

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Penn State Food Safety Blog

JULY 1, 2024

FDA issued a Warning Letter to a PA bakery operation. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them.

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Penn State Food Safety Blog

DECEMBER 4, 2024

FDA issued a Warning Letter to Mena Food Group, Fort Lauderdale, FL, after inspecting the facility which manufactures ready-to eat (RTE) bakery products including breads, cakes, and pastries. The issues seen here are things that have been previously cited with other bakery operations, as well as other operations producing RTE foods.

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