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

APRIL 26, 2024

g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §

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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. § We cannot fully evaluate this response because you did not provide for our review any documentation to evaluate this corrective action.

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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

MAY 20, 2024

Garcia: The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 681 Anita St, Ste 106, Chula Vista, CA 91911, from October 24 through November 28, 2023. Shorees, CEO Mr. Rene A. Garcia, President California Bread Co. It also addresses application of temporary or sticker labels (i.e.,

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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

AUGUST 4, 2023

This is such a case where this small Italian food company did not have a food safety plan, and along with that, did not have documented controls in place for allergens among other potential hazards. Looks to be a retail operation that is doing distribution. Many may feel that they are flying under the radar.

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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

DECEMBER 27, 2023

During the inspection, the FDA investigator found serious violations of the 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 Part CFR 117). Friedman Vice President Desserts by Helen, Inc.

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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. You can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, the Seafood HACCP regulation, and the CGMP & PC rule through links on FDA’s home page at www.fda.gov. Sincerely, /S/ Ronald M.

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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). Misbranding Violation: 3.

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Penn State Food Safety Blog

JULY 12, 2024

During the inspection of your facility, FDA investigators observed serious violations of the 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 23, 2024

[link] Discover Fresh Foods, LLC MARCS-CMS 677021 — JUNE 26, 2024 Recipient: Mr. Andrew Smart CEO Discover Fresh Foods, LLC 600 S. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Bruce, Director of Operations 211 Pine Rd.

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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

DECEMBER 11, 2024

However, The FDA noted that written sanitation procedures, documented on the (b)(4) Cleaning Checklist, for equipment used post-baking do not indicate sanitizer concentration or how to clean utensils and clean out-of-place (COP) equipment (e.g., However, in the Background section, the document indicates that (b)(4) for Salmonella sp.

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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

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 do not perform and document the review of labels for proper declaration of allergens. Sincerely, /S/ Darla R.

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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). Thong Manager Lucky K.T.

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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 20, 2024

Zheng: The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 1140 W Louisiana Avenue, Denver, Colorado from September 18, 2023 to October 23, 2023. You also indicate employees will be retrained on food safety and hygiene, which will be implemented (b)(4) and documented.

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Penn State Food Safety Blog

DECEMBER 4, 2024

During our inspection of your facility, FDA investigators found serious violations of the 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). Sincerely, /S/ Ramon A.

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