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. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov. Raju Chief Executive Officer High Quality Organics, Inc. 12101 Moya Blvd.

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Penn State Food Safety Blog

NOVEMBER 22, 2023

FDA issued a Warning Letter to Wan-Gee Foods of St. MARCS-CMS 660360 — NOVEMBER 09, 2023 Recipient: Samson Wang CEO/President Wan-Gee Foods, Inc. Louis, MO 63132 United States Issuing Office: Division of Human and Animal Food Operations West II United States November 9, 2023 FEI: 1000138918 CMS Case No.:

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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

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. These violations render the bottled water products processed at your facility adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. §

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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 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

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.

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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. In accordance with 21 CFR 123.6(g),

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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

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

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 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. Based on FDA’s inspectional findings, we have determined that you did not follow the requirements of the CGMP & PC rule.

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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

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. Specifically, 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

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

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

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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