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

JUNE 12, 2024

In documentation provided to FDA, the company indicated that Milk Chocolate Covered Peanut Butter brownies were unintentionally packed into the assortment box which was labeled to contain brownies containing macadamia nuts. 343(w)], in that the finished product label did not declare the major food allergen, peanuts. 585 Hinano St.

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Penn State Food Safety Blog

MARCH 13, 2024

In documentation provided to FDA on September 15, 2023, the firm stated that they had reformulated the bun product to include milk powder without changing the packaging to reflect the change. 343(w)], in that the finished product label did not declare a major food allergen, milk. Firas Hanna President Knickerbocker 365, Inc.

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Penn State Food Safety Blog

APRIL 26, 2024

We have reviewed the documentation and continue to have serious concerns with your HACCP program. We find your response inadequate in that you did not provide evidence/documentation to demonstrate your corrective actions or that employee training was performed. Your significant deviations are as follows: 1. b), (c)(4).

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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

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

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

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

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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Penn State Food Safety Blog

SEPTEMBER 5, 2024

We cannot fully evaluate this response because you did not provide for our review any documentation to evaluate this corrective action. We remain concerned that the (b)(4) for the treatment of product water is not operated in a manner that is effective in accomplishing the intended purpose. Sincerely, /S/ Darla R.

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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

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

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

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

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

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

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

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

JULY 1, 2024

Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Please reference CMS #674301 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

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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 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

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

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

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

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

JULY 1, 2024

To date, you have not provided any corrective actions or supporting documentation to demonstrate that you have adequately resolved this observation. You also indicated that you may consider replacing the PVC piping with stainless steel but did not commit to do so. Misbranding Violation: 3.

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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

JULY 12, 2024

Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. MARCS-CMS 679972 — JUNE 12, 2024 Recipient: Mr. Ramon Laguarta CEO PepsiCo, 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. 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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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

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

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

DECEMBER 4, 2024

We have reviewed these documents and found the products that you manufacture and distribute are not labeled in accordance with the Code of Federal Regulations, Title 21, Part 101, Food Labeling Regulation (21 CFR Part 101). Hernandez Program Division Director Office of Human and Animal Food Operations East IV Division

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