Penn State Food Safety Blog

OCTOBER 25, 2024

MARCS-CMS 680624 — September 11, 2024 Mr. Michael Louie, President Mr. Gordon Louie, Secretary Alfred Louie, Inc. 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. [link] Alfred Louie, Inc.

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Penn State Food Safety Blog

MAY 20, 2024

MARCS-CMS 675713 — APRIL 17, 2024 Recipient: Mr. Jason Y. We advised you of these WGS results via a conference call on January 5, 2024. Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 FDA Warning Letter [link] Ocean Group Inc. Kim CEO Ocean Group Inc. The presence of L.

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Food Safety News

JANUARY 8, 2024

Miller has never sought licenses for his retail food operations in Pennsylvania. To sign up for a free subscription to Food Safety News, click here.) With Pennsylvania, Michigan, and New York investigating the Shtiga-toxin illnesses involving eggnog and raw milk, more is going to be heard about what happened.

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Penn State Food Safety Blog

MARCH 8, 2024

MARCS-CMS 676447 — JANUARY 30, 2024 Recipient: Barsotti Juice Company, Inc. We have scheduled a regulatory meeting to be held through conference call on Wednesday, February 21, 2024 at 9:00 AM PST. Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

JULY 12, 2024

In April of 2024, the facility was closed. The WGS analysis confirmed the isolate to be Salmonella Cubana and the isolate did not match other food, environmental, or clinical isolates in the database. January 3, 2024 - We advised you of the WGS results via a conference call on January 3, 2024.

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Penn State Food Safety Blog

JUNE 12, 2024

WARNING LETTER [link] Midwest Foods, LLC MARCS-CMS 677464 — MAY 21, 2024 Recipient: Jordon P. Elwell CEO/Owner United States Issuing Office: Division of Human and Animal Food Operations West II United States WARNING LETTER Reference #: CMS 677464 Date: May 21, 2024 Dear Mr. Elwell: The U.S. Mitchell, Ph.D.

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Food Safety News

MARCH 3, 2024

In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on March 21 and 28, 2023, you indicated that your firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation.

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Penn State Food Safety Blog

MARCH 13, 2024

MARCS-CMS 673138 — JANUARY 29, 2024 Recipient: Mr. Firas Hanna President Knickerbocker 365, Inc. retail unit, lot codes I31C, J01C, J02C, J06C, J07C, J08C, J09C, & J11C (UPC 611625100206)) are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §

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Penn State Food Safety Blog

AUGUST 15, 2024

MARCS-CMS 677503 — July 08, 2024 Recipient: Mr. Boligala C. Reno, NV, from November 27 through December 07, 2023, and January 03 through January 04, 2024. Raju: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) spice facility, located at 12101 Moya Blvd., 12101 Moya Blvd.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA Warning Letter [link] Agila Corporation dba Woody’s Pet Food Deli MARCS-CMS 670835 — JANUARY 26, 2024 Recipient: Enrique A. Palma Owner Agila Corporation dba Woody’s Pet Food Deli 105 W. If you have questions you may contact Ms. Sanger at email Lauren.Sanger@fda.hhs.gov. 342(a)(1). 342(a)(4), and 21 CFR 507.1(a)(1)(ii).

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

Louis Calco, LLC MARCS-CMS 669917 — March 21, 2024 Recipient: Mr. Xiaohui Zhou Owner St. 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. Louis Calco, LLC 1336 W.

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Penn State Food Safety Blog

JULY 1, 2024

MARCS-CMS 674301 — JUNE 11, 2024 Recipient: Rick Dreiling CEO Dollar Tree Inc. 500 Volvo Parkway Chesapeake, VA 23320 United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER June 11, 2024 Dear Mr. Dreiling: Beginning in October 2023, the U.S.

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Penn State Food Safety Blog

MAY 20, 2024

MARCS-CMS 674283 — APRIL 25, 2024 Recipient: Mr. Steve S. Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 [link] WARNING LETTER California Bread Co. Shorees, CEO Mr. Rene A. Garcia, President California Bread Co. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov.

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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? Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

JULY 1, 2024

[link] McClure’s Lancaster Old Fashioned, LLC MARCS-CMS 670611 — MAY 16, 2024 Recipient: Mr. Thomas Keenan Owner & President McClure’s Lancaster Old Fashioned, LLC 1212 Reading Road Bowmansville, PA 17507 United States Issuing Office: Division of Human and Animal Food Operations East II United States WARNING LETTER CMS # 670611 May 16, 2024 Dear (..)

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Penn State Food Safety Blog

MARCH 27, 2024

D/B/A Flavor First Foods Inc. MARCS-CMS 668515 — MARCH 14, 2024 Recipient: Mr. Gregory Joao Silva Owner F1 Foods Inc. D/B/A Flavor First Foods Inc. Pace Program Division Director Office of Human and Animal Food Operations East – Division 1 Sincerely, /S/ Ronald M.

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Penn State Food Safety Blog

MAY 20, 2024

Therefore, you became aware that the affected batches of this food contained undeclared egg on or about April 3, 2023, but you have not submitted a report to the Reportable Food Registry as of March 13, 2024". MARCS-CMS 669669 — MARCH 19, 2024 Recipient: LuHua Lu, Owner Zun Xing Li, Owner JX Restaurants, Inc.

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Penn State Food Safety Blog

MAY 13, 2024

Bracy Program Division Director Office of Human and Animal Food Operations West Division 5 If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov. Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

MARCS-CMS 659663 — JANUARY 26, 2024 Recipient: Mr. Huu Q. Bracy Program Division Director Office of Human and Animal Food Operations - West Division 5 [link] WARNING LETTER Lucky K.T. Thong Manager Lucky K.T. Your written response should be sent electronically to: orahafwest5firmresponses@fda.hhs.gov. Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

[link] WARNING LETTER Brewing Market Coffee MARCS-CMS 682451 — April 25, 2024 Recipient: Artine G. Food and Drug Administration (FDA) conducted an inspection of your acidified manufacturing facility located at 5775 Arapahoe Ave, Boulder, Colorado from December 14, 2023, through January 25, 2024. You may reach Ms.

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Penn State Food Safety Blog

JULY 1, 2024

MARCS-CMS 672140 — JUNE 17, 2024 Recipient: Tony Gavin Bimbo Bakeries USA, Inc. Mark Harris Program Division Director Office of Human and Animal Food Operations – West Division 4 Cc: Zeeshan NMI Hafiz, Director of Operations Bimbo Bakeries USA, Inc. [link] WARNING LETTER Bimbo Bakeries USA, Inc. You may reach Ms.

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Penn State Food Safety Blog

MAY 20, 2024

DBA Kwan Sang Noodle Company MARCS-CMS 672206 — APRIL 23, 2024 Recipient: Wei Chi Zheng Owner Ng Zheng Inc. Food and Drug Administration; Attn: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov or at 6th Ave and Kipling St, DFC Bldg. [link] Ng Zheng Inc. 20, PO Box 25087, Denver, Colorado. You may reach Ms.

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Penn State Food Safety Blog

DECEMBER 4, 2024

link] Mena Food Group, LLC MARCS-CMS 673814 — August 08, 2024 Recipient: Mr. David Mena Owner/President Mena Food Group, LLC 4710 NW 15th Ave Ste 5a-2 Fort Lauderdale, FL 33309-3785 United States david@bakerymilitellos.co Hernandez Program Division Director Office of Human and Animal Food Operations East IV Division

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