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 may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.

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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

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. We also address your responses below.

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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

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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Modern Restaurant Management

SEPTEMBER 14, 2021

Sandra (Sandy) Reinhardt: Vice President of Information Technology | 30 years. She moved to information technology in 1994 where she was instrumental in putting in the first network and email system for SBCI. Paul Soulliere: Information Systems Manager | 25 years. Sandy Reinhardt joined Schostak Brothers & Co.,

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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

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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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. [link] WARNING LETTER Dollar Tree Inc. MARCS-CMS 674301 — JUNE 11, 2024 Recipient: Rick Dreiling CEO Dollar Tree Inc.

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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

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

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

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

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

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

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. This includes any operation that involves direct contact of food and other surfaces.”

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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

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

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

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

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

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 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

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

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

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

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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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

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

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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Bill Marler

DECEMBER 8, 2019

Of 15 people with available information, 9 (60%) were hospitalized. In interviews, ill people answered questions about the foods they ate and other exposures in the 2 to 7 weeks before they became ill. In interviews, ill people answered questions about the foods they ate and other exposures in the 2 to 7 weeks before they became ill.

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Food Safety News

AUGUST 12, 2023

— OPINION — On July 29 the International Food Industry Think Tank discussed “Energizing Food Safety and Quality Assurance Transformation Process.” That discussion inspired the launching of the Safety, Security, and Quality Assurance (2S-QA) Movement on Aug. 2022, December).

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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.

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