Penn State Food Safety Blog

NOVEMBER 22, 2023

Personal hygiene issues - did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required by 21 CFR 117.10(b).

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Penn State Food Safety Blog

MARCH 8, 2024

WARNING LETTER [link] Gilster-Mary Lee Corporation MARCS-CMS 658271 — AUGUST 28, 2023 Recipient: Mr. Thomas B. 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. §

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Food Safety News

MARCH 11, 2024

The Food and Drug Administration is requesting 7.4 1, 2023, and runs through Sept. Problems with inspections related to imported food came to light in the fall of 2023 when it was discovered that cinnamon applesauce marketed for children in the United States and imported from Ecuador was contaminated with lead.

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Penn State Food Safety Blog

APRIL 26, 2024

O’Donnell: The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4481 Johnston Parkway, Cleveland Ohio from July 10 to July 25, 2023. You provided a written response to the inspection on August 11, 2023, which included corrective actions taken by your firm.

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

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. We address your responses below.

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Penn State Food Safety Blog

JULY 1, 2024

From the Warning Letter, "On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s voluntary recall of Apple Cinnamon Fruit Puree pouches.

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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 acknowledge your written responses dated April 6, 14, and 20, 2023.

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Penn State Food Safety Blog

MAY 20, 2024

Most notably, one of these strains was identified in twenty-eight (28) isolates and matched four (4) clinical isolates (2017, 2018, 2019, and 2023), indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility." Consuming foods contaminated with L.

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Penn State Food Safety Blog

DECEMBER 27, 2023

Cleaning Did not clean non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination, Improper Storage Did not store food under conditions that protect against contamination of food, as required by 21 CFR § 117.93. 14100 Auto Park Way Ste.

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Penn State Food Safety Blog

JULY 23, 2024

According to the report, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for L. monocytogenes isolates obtained from FDA environmental sample 124288 in 2023; four (4) L. monocytogenes. monocytogenes. USDA FSIS detected L.

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Penn State Food Safety Blog

JULY 12, 2024

This facility issued a recall of product for Salmonella in December of 2023. On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023. In April of 2024, the facility was closed.

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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. The incident continued into 2023.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

In June of 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected Iowa Egg Company Inc.'s 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 2010 Holmes Rd.

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Penn State Food Safety Blog

MAY 20, 2024

Your hazard analysis for your various bread products (part of your HACCP Plan dated November 2, 2023) identified allergens as a significant hazard requiring a Critical Control Point (CCP) at the packaging/labeling step. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No.

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Penn State Food Safety Blog

OCTOBER 27, 2023

MARCS-CMS 653966 — AUGUST 21, 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. We received your written responses on February 9, March 1, and April 5, 2023.

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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. But is that enough?

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Penn State Food Safety Blog

MARCH 27, 2024

On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan.

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Penn State Food Safety Blog

JUNE 12, 2024

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. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility, located at 1802 N.

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Penn State Food Safety Blog

DECEMBER 27, 2023

MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A. Friedman: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility located at 283 Thompson Avenue, Louisville, KY 40206 from February 27 through March 13, 2023. [link] Desserts by Helen, Inc.

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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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Food Safety News

JANUARY 11, 2024

The reorganization of the Food and Drug Administration’s human foods program began in 2023 with the appointment of Jim Jones to be the agency’s first-ever deputy commissioner for human foods. Jones is a 30-year veteran of the Environmental Protection Agency.

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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., As examples: a.

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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

MARCH 8, 2024

Kraft Road West Saint Paul, MN 55118 United States Issuing Office: Division of Human and Animal Food Operations West I United States January 26, 2024 WARNING LETTER Refer to CMS 670835 Dear Mr. Palma: The U.S. 2 Furthermore, you are using the unapproved/unsafe animal food additive peroxyacetic acid (PAA). 342(a)(1). a)(1)(ii).

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Penn State Food Safety Blog

MAY 13, 2024

Kao: The United States Food and Drug Administration (FDA) inspected your manufacturing and distributing facility, located at 201 S Hill Dr, Brisbane, CA 94005, on August 14 through 31, 2023. You provided a response to the inspection on September 21, 2023, describing corrective actions taken by your firm. Specifically, a.

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Penn State Food Safety Blog

AUGUST 4, 2023

[link] Porfirios Italian Foods, Inc. MARCS-CMS 656454 — JUNE 21, 2023 Recipient: Mr. Robert Calabro Owner Porfirios Italian Foods, Inc. You provided a response to the inspection on March 29, 2023, describing corrective actions taken by your firm. You do not have this program in place.

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Penn State Food Safety Blog

DECEMBER 27, 2023

During a June 2023 inspection of the facility, FDA found Listeria in the facility as well as identified many GMP issues related to cleaning and poor equipment. monocytogenes positive swabs was collected from the food contact surface of a cutting board that was being used to cut RTE Jersey Girl cheese. monocytogenes." monocytogenes."

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

A second analysis of lot WB123275, conducted on December 27, 2023, identified Paecilomyces lilacinus. Bracy Program Division Director Office of Human and Animal Food Operations – West Division 5 Ryan Emmons CEO Waiakea Bottling Inc. If you have any questions regarding this letter, please contact Elodie X. Sincerely, /S/ Darla R.

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Penn State Food Safety Blog

APRIL 26, 2024

[link] Appleton City Feed Service LLC MARCS-CMS 662279 — NOVEMBER 01, 2023 Recipient: Ms. 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. Smith, The U.S.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). You do not have this program in place.

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Penn State Food Safety Blog

MAY 20, 2024

FDA laboratory analysis of environmental sample 1216621 collected on August 9, 2023, from various areas in your processing facility during production found that eight (8) out of 111 swabs were confirmed positive for L. August 30, 2023, non-food contact environmental swabs collected from your facility." monocytogenes.

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Penn State Food Safety Blog

JULY 1, 2024

During our inspection of your facility, the FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

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Penn State Food Safety Blog

DECEMBER 13, 2023

[link] Nutra Blend, LLC subsidiary of Land O’Lakes MARCS-CMS 651174 — MAY 22, 2023 Product: Animal & Veterinary Drugs Food & Beverages Recipient: Ms. 4 Furthermore, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is reportable (i.e.,

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Food Safety News

AUGUST 12, 2023

The premise for this movement comes from this understanding: “If we do not energize the Food Industry Transformation Process through the direct actions of every stakeholder, our good intentions, aspirations, and proposals will only hover aimlessly in the space of academic and theoretical discourse without realizing desirable results.”

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Penn State Food Safety Blog

MAY 20, 2024

The inspection revealed significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

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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

SEPTEMBER 25, 2024

The company "failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. You may reach Ms.

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