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. § we make one product that meets every FDA requirement for infant formula.

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

FDA issued a Warning Letter to St. Louis Calco, a sprout operation located in Fenton, MO. Lark Industrial Dr. 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).

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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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Bill Marler

DECEMBER 8, 2019

Based on available traceback data, the FDA requested that industry voluntarily withdraw romaine lettuce grown in Salinas, California from the market and is requesting that the industry withhold distribution of romaine for the remainder of the growing season in Salinas. Illnesses started on dates ranging from September 24 to November 18.

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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

MARCH 13, 2024

FDA issued a Warning Letter to a Michigan firm after the firm failed to respond to FDA's request to provide corrective actions related to a recall the firm had conducted. The message here, respond to FDA requests. 343(w)], in that the finished product label did not declare a major food allergen, milk.

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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). Food and Drug Administration (FDA) conducted an inspection of your non-FDA licensed medicated feed mill located at 302 W.

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Penn State Food Safety Blog

OCTOBER 25, 2024

FDA issues a Warning Letter to Alfred Louie Inc, a sprouting operation and noodle manufacturing facility, located in Bakersfield, CA. Bakersfield, CA 93313 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER September 11, 2024 WL 680624 Dear Messrs.

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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. FDA and state partners also collected and analyzed additional product samples of fruit puree and applesauce pouches. 331(c)].

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Penn State Food Safety Blog

FEBRUARY 14, 2024

FDA issued a Warning Letter to an Indiana bakery that did not have proper label controls in place for sesame. FDA stated they will verify implementation of any corrective actions during FDA’s next inspection of the facility. 343(w)], in that the finished product label did not declare a major food allergen, sesame.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Barsotti Juice Company, Inc. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations.

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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. Raju: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) spice facility, located at 12101 Moya Blvd., Raju Chief Executive Officer High Quality Organics, Inc. 12101 Moya Blvd.

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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

DECEMBER 11, 2024

FDA issued a Warning Letter to Knickerbocker 365 Inc, a processor of ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located in Madison Heights, MI. This points out many of the same issues identified in bakery operations. pieces of equipment (i.e., Sokana: The U.S.

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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. To date, FDA has not received a response describing corrective actions. Osage, IA 50461.

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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". On January 10, 2023, you initiated a voluntary Class I recall of this animal food due to excessive monensin.

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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

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. WARNING LETTER [link] Midwest Foods, LLC MARCS-CMS 677464 — MAY 21, 2024 Recipient: Jordon P.

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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

JUNE 12, 2024

FDA issued a Warning Letter to Big Island Candies, Inc. of Hilo, HI after the company recalled their Big Island Candies Makana Brownie Assortment Box for not declaring the major food allergen, peanuts, finished product label. 343(w)], in that the finished product label did not declare the major food allergen, peanuts.

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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

APRIL 26, 2024

FDA issued a Warning Letter to Euro USA Inc seafood processing facility in Cleveland Ohio. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. The critical limit indicates you may receive scombroid fish with gel packs.

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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 (5.2 343(w)], in that the finished product label did not declare a major food allergen, milk.

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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. On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. In April of 2024, the facility was closed.

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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

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. D/B/A Flavor First Foods Inc. D/B/A Flavor First Foods Inc.

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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. FDA received your written response to the inspection via email on March 30, 2023, describing the corrective actions you have taken and plan to take.

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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. At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. 379e(a)].

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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. At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. I, Houston, TX on August 7 through 15, 2023.

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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

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

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? 331(d), 355(a)].

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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. Additionally, FDA collected environmental samples (i.e., Additionally, FDA collected environmental samples (i.e.,

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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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