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

MAY 20, 2024

However, your response cannot be fully evaluated due to of a lack of supporting documentation, such as environmental swab results for the staging room/warehouse areas that were found positive and sanitation monitoring records. training documents, photographs of corrections). MARCS-CMS 675713 — APRIL 17, 2024 Recipient: Mr. Jason Y.

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Food Safety News

JANUARY 11, 2024

While the changes may sound like Jones and Califf are merely shuffling the deck of bureaucracy within the agency’s food operations, I am hopeful that the changes will make a difference. The proposed reorganization of the FDA also includes creating new offices and shifting responsibilities from some offices to others.

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Penn State Food Safety Blog

FEBRUARY 19, 2024

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 You have a document titled “SE Prevention Plan”; however, as describedbelow, this plan is inadequate in that it does not address all required SE prevention measures. 2010 Holmes Rd.

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Penn State Food Safety Blog

MAY 20, 2024

We received your response describing corrective actions to the FDA-483 on December 13, 2023, with additional documentation received on December 20 and 21, 2023. Furthermore, you have not provided supporting documentation demonstrating you have implemented the finished product label check for allergen declarations.

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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. You also submitted a copy of “EFF.QA.SOP.155 Sincerely, /S/ William R.

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Penn State Food Safety Blog

MAY 20, 2024

We cannot evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate a preventive control, including applicable preventive control management components, is in place to adequately control the hazard of undeclared allergens.

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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

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. However, you have not provided your food safety plan following the target completion date of April 15, 2023.

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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

FEBRUARY 14, 2024

We cannot assess the adequacy of your stated corrective actions because you have not provided documentation such as your training records, cleaning procedures or sanitation monitoring records. (b)(5). Further, you indicated that you will inspect the equipment and utensils (b)(4) and document the inspection. Thong Manager Lucky K.T.

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Penn State Food Safety Blog

DECEMBER 13, 2023

Nutra Blend, LLC subsidiary of Land O’Lakes 4001 Lexington Avenue North Arden Hills, MN 55126 United States Issuing Office: Division of Human and Animal Food Operations West II United States May 22, 2023 WARNING LETTER CMS # 651174 Dear Ms. Reportable Food Registry (RFR) 3. Deverell, The U.S.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA Warning Letter [link] Agila Corporation dba Woody’s Pet Food Deli MARCS-CMS 670835 — JANUARY 26, 2024 Recipient: Enrique A. Palma Owner Agila Corporation dba Woody’s Pet Food Deli 105 W. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

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Penn State Food Safety Blog

MAY 20, 2024

As documented through the L. These activities will be documented on your Master Cleaning and Sanitation schedule form. Per CCP #(b)(4), product temperatures at the chilling step are to be documented on the record titled, “HACCP (b)(4) Temperature Log.” However, you informed our investigator that you do not collect (b)(4) swabs.

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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

MAY 13, 2024

Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label, as required by 21 CFR 117.135(c)(2)(ii). 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

DECEMBER 27, 2023

You must establish and maintain records that document your employees received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties, as required by 21 CFR 117.4.

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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? Sincerely, /S/ Darla R.

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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. Pace Program Division Director Office of Human and Animal Food Operations East – Division 1 If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time frame within which you will do so.

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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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