Penn State Food Safety Blog

JUNE 12, 2024

In documentation provided to FDA, the company indicated that Milk Chocolate Covered Peanut Butter brownies were unintentionally packed into the assortment box which was labeled to contain brownies containing macadamia nuts. Misbranding: Peanuts are considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. §

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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

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.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

On March 28, 2023, the company provided documents which indicated that they determined the root cause to be a “lack of label control,” as the receiver accepted incorrect packaging into the plant and the bagger operator used incorrect packaging that did not contain the correct allergen labeling.

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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.

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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

APRIL 26, 2024

We have reviewed the documentation and continue to have serious concerns with your HACCP program. 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."

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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

MARCH 13, 2024

In documentation provided to FDA on September 15, 2023, the firm stated that they had reformulated the bun product to include milk powder without changing the packaging to reflect the change. 343(w)], in that the finished product label did not declare a major food allergen, milk. Firas Hanna President Knickerbocker 365, Inc.

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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

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. You also submitted a copy of “EFF.QA.SOP.155 Sincerely, /S/ William R.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51°F to 68°Fconsecutively for 31 days." "Did You have a document titled “SE Prevention Plan”; however, as describedbelow, this plan is inadequate in that it does not address all required SE prevention measures. 2010 Holmes Rd.

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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

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

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

MAY 20, 2024

However, your response cannot be fully evaluated due to of a lack of supporting documentation, such as environmental swab results for the staging room/warehouse areas that were found positive and sanitation monitoring records. training documents, photographs of corrections). MARCS-CMS 675713 — APRIL 17, 2024 Recipient: Mr. Jason Y.

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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

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

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

MAY 20, 2024

We received your response describing corrective actions to the FDA-483 on December 13, 2023, with additional documentation received on December 20 and 21, 2023. Furthermore, you have not provided supporting documentation demonstrating you have implemented the finished product label check for allergen declarations.

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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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

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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.” Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Barber Program Division Director Division 5 Office of Human and Animal Food Operations-East

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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. Reportable Food Registry (RFR) 3. Deverell, The U.S. 21 CFR 507.50(b)(1).)

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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

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. As documented through the L. monocytogenes.

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Penn State Food Safety Blog

DECEMBER 27, 2023

I Houston, TX 77083-5887 United States Issuing Office: Division of Human and Animal Food Operations West III United States December 5, 2023 WARNING LETTER CMS #668767 Dear Mr. Yassir: The United States Food and Drug Administration (FDA) inspected your refrigerated, frozen, and ambient food product warehouse located at 14100 Auto Park Way Ste.

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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 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

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

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

JULY 12, 2024

Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. MARCS-CMS 679972 — JUNE 12, 2024 Recipient: Mr. Ramon Laguarta CEO PepsiCo, Inc.

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Penn State Food Safety Blog

DECEMBER 27, 2023

Sharon Tomaselli Co-Owners Cooperstown Cheese Company, LLC 107 Oxbow Road Milford, NY 13807-1131 United States Issuing Office: Division of Human and Animal Food Operations East I United States WARNING LETTER CMS # 667551 11/24/2023 Dear Mr. Sweitzer and Ms. Sweitzer and Ms. Milford, NY 13807-1131 from June 21 through July 28, 2023.

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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

Yapoujian Owner/President Brewing Market Coffee 5775 Arapahoe Ave Boulder, CO 80303-1331 United States Issuing Office: Division of Human and Animal Food Operations West IV United States April 25, 2024 WARNING LETTER Ref: CMS Case 682451 Dear Mr. Yapoujian: The U.S. You may reach Ms. Sincerely, /S/ E.

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Penn State Food Safety Blog

JULY 1, 2024

255 Business Center Drive Horsham, PA 19044 United States tony.gavin@grupobimbo.com Issuing Office: Division of Human and Animal Food Operations West IV United States June 17, 2024 WARNING LETTER Ref: CMS Case #672140 Dear Mr. Gavin: This is to advise you that the U.S. You may reach Ms. Sincerely, /S/ E.

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Penn State Food Safety Blog

DECEMBER 4, 2024

We have reviewed these documents and found the products that you manufacture and distribute are not labeled in accordance with the Code of Federal Regulations, Title 21, Part 101, Food Labeling Regulation (21 CFR Part 101). Hernandez Program Division Director Office of Human and Animal Food Operations East IV Division

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