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

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

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

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 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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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.

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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. the listing regulation for FD&C Yellow No. In the inspection, FDA found inadequate allergen controls.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

These violations render the bottled water products processed at your facility adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § A second analysis of lot WB123275, conducted on December 27, 2023, identified Paecilomyces lilacinus. Ryan Emmons CEO Waiakea Bottling Inc.

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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

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 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

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

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

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

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

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

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

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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Penn State Food Safety Blog

DECEMBER 4, 2024

At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day. Mena: The United States Food and Drug Administration (FDA) inspected your facility located at 4710 NW 15th Ave Ste 5a-2, Fort Lauderdale, FL from October 30, 2023, to November 20, 2023.

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