Penn State Food Safety Blog

DECEMBER 11, 2024

The hazard analysis indicates that it was approved by the President/Owner (Sandra Sokana) who is not a PCQI, and there is no PCQI trained individuals or individuals who are qualified through experience to develop and apply a food safety system. link] WARNING LETTER Knickerbocker 365 Inc. Sokana President/Owner Knickerbocker 365 Inc.

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Food Safety News

JANUARY 8, 2024

As he has in the past, Amos Miller has turned to his supporters for financial assistance as he finds compliance with food safety regulations troublesome. The basis of the order was an affidavit from Sheri Morris, the Department of Agriculture’s acting food safety director. 4 under a warrant signed on Jan. Dennis Commins.

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Food Safety News

MARCH 11, 2024

“This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public health and mission-support capacity, and modernize the FDA’s infrastructure and facilities.”

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Food Safety News

OCTOBER 18, 2023

It was published by New Zealand Food Safety (NZFS), a Ministry for Primary Industries (MPI) unit. Most 27 outbreaks, with 253 cases in 2022, were linked to commercial food operators, and only five were associated with food prepared in consumer homes. New Zealand Food Safety investigated two more outbreaks.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

Also, "the process controls did not include, as appropriate to the nature of the applicable control and its role in the facility's food safety system, parameters associated with the control of a hazard, as required by 21 CFR 117.135(c)(1)(i)" [link] Waiakea Bottling Inc. Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

JUNE 12, 2024

Hilo, HI 96720-4428 United States Issuing Office: Division of Human and Animal Food Operations West V United States May 29, 2024 WL 681107 Dear Ms. Misbranding: Peanuts are considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. § WARNING LETTER [link] Big Island Candies, Inc. 585 Hinano St. 321(qq)].

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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. MARCS-CMS 656454 — JUNE 21, 2023 Recipient: Mr. Robert Calabro Owner Porfirios Italian Foods, Inc.

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Penn State Food Safety Blog

NOVEMBER 22, 2023

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.: 10849 Midwest Industrial Blvd. 660360 WARNING LETTER Dear Mr. Wang: The U.S.

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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)). You did not conduct a reanalysis of your food safety plan when needed, as required by 21 CFR 117.170. 12101 Moya Blvd.

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Penn State Food Safety Blog

OCTOBER 25, 2024

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. Louie: The Food and Drug Administration (FDA) conducted an inspection of your sprouting operation and noodle manufacturing facility, located at 4501 Shepard St.,

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Penn State Food Safety Blog

OCTOBER 27, 2023

Did not prepare, or have prepared, and did not implement a written food safety plan, as required by 21 CFR 507.31(a). Kansas Avenue Frankfort, KS 66427-1331 United States Issuing Office: Division of Human and Animal Food Operations West II United States August 21, 2023 WARNING LETTER CMS # 653966 Dear Dr. Johll, The U.S.

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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

DECEMBER 27, 2023

This includes any operation that involves direct contact of food and other surfaces.” Barber Program Division Director Division 5 Office of Human and Animal Food Operations-East MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A. Friedman Vice President Desserts by Helen, Inc. Sincerely, /S/ Steven B.

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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

APRIL 26, 2024

4th Street Appleton City, MO 64724-1406 United States Issuing Office: Division of Human and Animal Food Operations West II United States November 1, 2023 WARNING LETTER CMS # 662279 Dear Ms. Food and Drug Administration (FDA) conducted an inspection of your non-FDA licensed medicated feed mill located at 302 W. Smith, The U.S.

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Penn State Food Safety Blog

APRIL 26, 2024

c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." Barber Director, Division V Office of Human and Animal Foods Operations-East

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Penn State Food Safety Blog

NOVEMBER 8, 2023

Food and Drug Administration (FDA) conducted an inspection of your vitamin and mineral premix and preblend animal food manufacturing facility, located at 1200 McGrath Avenue, Effingham, Illinois 62401 on March 13 through March 16, 2023. Sincerely, /S/ William R.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

retail unit, UPC #0-70253-75107-3) manufactured between February 9, 2023 and March 20, 2023 are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, sesame. Sincerely, /S/ William R.

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Penn State Food Safety Blog

JULY 1, 2024

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. Oxenham, JD Director Office of Compliance Center for Food Safety and Applied Nutrition U.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. Sincerely, /S/ LaTonya M.

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Modern Restaurant Management

SEPTEMBER 14, 2021

. “AI-powered robots play a primary role in the future of food service, and Blendid is committed to not only optimizing the consumer experience, but also helping food operators overcome labor shortages and post-pandemic demand complexities while improving operator margins. OpsAnalitica Teams with FreshFry.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

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. Bracy Program Division Director Office of Human and Animal Food Operations - West Division 5 Hendricks: The U.S.

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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. FDA issued a Warning Letter to Lucky K.T. cereus and C.botulinum.

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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

MARCH 8, 2024

retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 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 23, 2024

[link] Discover Fresh Foods, LLC MARCS-CMS 677021 — JUNE 26, 2024 Recipient: Mr. Andrew Smart CEO Discover Fresh Foods, LLC 600 S. Your packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation1 lethal to the pathogen) that would significantly minimize the pathogen.

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Penn State Food Safety Blog

MARCH 13, 2024

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. § 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 8, 2024

2239 Hidden Valley Lane Camino, CA 95709 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER January 30, 2024 WL 676447 Dear Mr. Barsotti: We inspected your juice processing facility, located at 2239 Hidden Valley Lane, Camino, CA on November 20, November 21 and December 1, 2023.

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Penn State Food Safety Blog

MARCH 27, 2024

Gregory Joao Silva Owner F1 Foods Inc. D/B/A Flavor First Foods Inc. Food and Drug Administration Center for Food Safety and Applied Nutrition 5001 Campus Dr. (HFS-681) College Park, MD 20740 You may also submit your waiver request by email to FURLS@fda.gov. 342 and § 343(w)]. Sincerely, /S/ Ronald M.

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Penn State Food Safety Blog

MAY 20, 2024

Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 MARCS-CMS 675713 — APRIL 17, 2024 Recipient: Mr. Jason Y. Kim CEO Ocean Group Inc. If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov or 510-337-6870.

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Penn State Food Safety Blog

MAY 20, 2024

Li: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) rice and noodle-based meals manufacturing facility, located at 64 Weldon Pkwy, Maryland Heights, MO from August 8, through September 1, 2023. 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

SEPTEMBER 25, 2024

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. Food and Drug Administration (FDA) inspected your sprout operation, located at 1336 W. Louis Calco, LLC 1336 W.

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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

Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 Shorees, CEO Mr. Rene A. Garcia, President California Bread Co. 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

DECEMBER 13, 2023

Nutra Blend, LLC subsidiary of Land O’Lakes 4001 Lexington Avenue North Arden Hills, MN 55126 United States Issuing Office: Division of Human and Animal Food Operations West II United States May 22, 2023 WARNING LETTER CMS # 651174 Dear Ms. Lisa Deverell President, Purina Animal Nutrition; Executive Vice President, Land O’ Lakes, Inc.

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Penn State Food Safety Blog

AUGUST 30, 2024

WARNING LETTER [link] P&L Bean Sprout Farm MARCS-CMS 680777 — July 31, 2024 Recipient: Haoyang Pei Owner P&L Bean Sprout Farm 266 Forest Manor Rd Cochranville, PA 19330 United States Issuing Office: Division of Human and Animal Food Operations East II United States WARNING LETTER CMS #680777 July 31, 2024 Dear Ms. Pei, The U.S.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

MARCS-CMS 663904 — DECEMBER 15, 2023 Recipient: Danny Dang Director/Owner Iowa Egg Company Inc. 2010 Holmes Rd. Osage, IA 50461.

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