Penn State Food Safety Blog

AUGUST 15, 2024

The company did not conduct a reanalysis of your food safety plan when needed after Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)). MARCS-CMS 677503 — July 08, 2024 Recipient: Mr. Boligala C. link] WARNING LETTER High Quality Organics, Inc. 12101 Moya Blvd.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

dba Sammy’s Milk MARCS-CMS 682538 — August 14, 2024 Recipient: Erin Hendricks President Graceleigh, Inc. dba Sammy’s Milk 3471 Via Lido, Ste 207 Newport Beach, CA 92663 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER August 14, 2024 WL 682538 Dear Ms.

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Penn State Food Safety Blog

JULY 23, 2024

Then in 2024, additional sampling by USDA found Listeria. monocytogenes was detected in two (2) additional environmental swabs collected from non-food-contact surfaces (e.g., link] Discover Fresh Foods, LLC MARCS-CMS 677021 — JUNE 26, 2024 Recipient: Mr. Andrew Smart CEO Discover Fresh Foods, LLC 600 S.

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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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Penn State Food Safety Blog

AUGUST 30, 2024

This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. Food and Drug Administration (FDA) inspected your sprouting operation, located at 266 Forest Manor Road, Cochranville, Pennsylvania, from January 31, 2024, through March 12, 2024.

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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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Penn State Food Safety Blog

MAY 13, 2024

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. However, you did not have a food safety plan with any of the required elements.

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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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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

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

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. Sincerely, /S/ Ann M.

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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

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. In addition, a qualified facility is required by 21 CFR 507.7(a)(2) If you have questions you may contact Ms. 342(a)(1). a)(1)(ii).

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Penn State Food Safety Blog

FEBRUARY 14, 2024

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. MARCS-CMS 659663 — JANUARY 26, 2024 Recipient: Mr. Huu Q.

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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. The waiver request should include the facility name and address and the name of the owner, operator, or agent in charge of the facility. 342 and § 343(w)].

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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

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

JULY 1, 2024

Note that preventive controls are subject to preventive control management components (monitoring, verification and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

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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

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. Hopefully other noodle companies are noting the coming attention and are prepared with a well written Food Safety Plan. link] Ng Zheng Inc.

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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

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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