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. Holi: The United States Food and Drug Administration (FDA) has determined that your recalled Big Island Candies Makana Brownie Assortment Box (sold in 10 oz. 585 Hinano St.

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Food Safety News

MARCH 11, 2024

million of the proposed budget would support the FDA’s “public health employee workforce,” though the agency did not specify how much money would go toward food operations. million is requested to modernize data infrastructure to support agency operations.

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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

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. 21 CFR 101.9(c) c) and (d)].

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Food Safety News

AUGUST 12, 2023

Visit the web site for additional information: [link] References Amiri, F. Global Consumer Protection SSQA Development and Implementation: A Manual for the Food Industry. Regulators are expected to maintain their role of enforcing the laws and regulations as the only necessary and legally enforced rules. 2022, December).

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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

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

MARCH 8, 2024

During the inspection, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24, at a location immediately after the application of the spray and immediately prior to finished product packaging. Palma Owner Agila Corporation dba Woody’s Pet Food Deli 105 W.

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Penn State Food Safety Blog

AUGUST 15, 2024

Reno, NV 89506-2600 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER July 8, 2024 WL CMS# 677503 Dear Mr. 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

SEPTEMBER 5, 2024

Upon request, you provided a revised Food Safety Plan on April 3, 2024. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your responses below.

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Penn State Food Safety Blog

JULY 1, 2024

The receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation of section 301(c) of the FD&C Act [21 U.S.C. § This call was to inform you of reports of product still being offered on shelves at Dollar Tree stores in several locations.

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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

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

MAY 20, 2024

The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., 379e(a)].

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Penn State Food Safety Blog

JULY 12, 2024

In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § Chewy (b)(4)). Jackson Blvd., Chicago, IL 60661.

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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. We encourage you to refine and consistently implement your mycotoxin hazard prerequisite program.

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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.: You should provide this information in your response to this letter.

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Penn State Food Safety Blog

MAY 20, 2024

If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.

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Penn State Food Safety Blog

MARCH 27, 2024

It seems this facility was operating as if not regulations exist. Gregory Joao Silva Owner F1 Foods Inc. D/B/A Flavor First Foods Inc. Your significant violations are as follows: Acidified Foods Violations (21 CFR Part 108 and 114): 1. However, if you look at their website, you would think this place was outstanding.

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Penn State Food Safety Blog

DECEMBER 11, 2024

26040 Pinehurst Dr. Madison Heights, MI 48071 United States Issuing Office: Office of Human & Animal Food Operations East 6 550 W. You may find the Act and further information about the CGMP & PC rule through links in FDA's internet home page at www.fda.gov. MARCS-CMS 687624 September 30, 2024 Recipient: Sandra T.

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Penn State Food Safety Blog

JULY 1, 2024

The inspection also revealed that certain products manufactured in your facility are misbranded because, among other things, the labels for certain products declare the major food allergen of “peanut” as an ingredient which is not intentionally introduced in the formulation of those products, which is false or misleading.1 Specifically, a.

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Penn State Food Safety Blog

APRIL 26, 2024

If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please send your reply to the Food and Drug Administration, Attention: Allison Hunter, Compliance Officer, 550 Main Street, Suite 4-930, Cincinnati, Ohio 45202. Sincerely, /S/ Steven B.

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Mise Designs

FEBRUARY 25, 2021

Customers are also usually informed that they should not bother sleeping animals, pick up animals, chase them or use any sort of flash photography on the premises. Where this plan separates some while opening an animal cafe is ensuring that the drink and food operations are legally and safely being done.

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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. 343(q)] in that the nutrition information (e.g.

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Penn State Food Safety Blog

AUGUST 4, 2023

MARCS-CMS 656454 — JUNE 21, 2023 Recipient: Mr. Robert Calabro Owner Porfirios Italian Foods, Inc. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. Libby at U.S.

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Penn State Food Safety Blog

MAY 13, 2024

Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. You may find the Act and further information through links on FDA's website at [link] At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations.

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Penn State Food Safety Blog

DECEMBER 27, 2023

After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. Food and Drug Administration; Attn: Allison C. MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A.

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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. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. Bruce, Director of Operations 211 Pine Rd.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

Based on our review of the inspectional findings, we are issuing this letter to advise you of our concerns and to provide detailed information describing the findings at your farm. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kara L. 2010 Holmes Rd. Osage, IA 50461.

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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

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

DECEMBER 13, 2023

Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption.are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Deverell, The U.S. 21 CFR 507.50(b)(1).)

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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. Food and Drug Administration, Attention: Michael E. Sweitzer and Ms.

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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

OCTOBER 27, 2023

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. Food facility registration guidance is available online at [link] Registration may be accomplished online at www.access.fda.gov.

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Penn State Food Safety Blog

MAY 20, 2024

Reportable Food Registry - Failure to report. Specifically, you informed our investigator that on April 3, 2023, your customer conducted a recall on LuLu Chinese Express brand Korean Noodles with Vegetables with a Sell By date of April 11, 2023, due to an undeclared major food allergen, egg. Misbranding - numerous issues.

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