Bill Marler

SEPTEMBER 2, 2021

Food Safety and Inspection Service. FSIS-2020-0007; Document ID FSIS-2020-0007-0001 – Petition for an Interpretive Rule declaring ‘Outbreak’ Serotypes of Salmonella enterica subspecies enterica to be Adulterants Within the Meanings of 21 U.S.C. § 2011) (applying 5 USC § 555(b) to an FDA citizen’s petition); Fund for Animals v.

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Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a low acid canned food (LACF) facility, located on Huarong County, Yueyang, Hunan, China. Did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35 Xia Wang: The U.S.

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Penn State Food Safety Blog

JANUARY 11, 2024

The FDA issued the first CORE (Coordinated Outbreak Response & Evaluation Network) annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year. FDA published a strategy summary to prevent Listeria from Enoki mushrooms.

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Penn State Food Safety Blog

SEPTEMBER 27, 2023

The FDA Hazards Guide is a document intended to help with the compliance of meeting specific Preventive Controls for Human Food regulations. It has been an ongoing effort, with FDA releasing sections as they are completed. This week, FDA released two new sections, one of those focused on allergen control.

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Food Safety News

JANUARY 7, 2024

Business owners have 15 days to respond to FDA warning letters. Houston, TX A food firm in Texas is on notice from the FDA of severe violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. US Gulf Coast Trading Co.

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Penn State Food Safety Blog

AUGUST 15, 2024

FDA issued a Warning Letter to High Quality Organics, a ready-to-eat (RTE) spice facility, located in Reno, NV. Did not maintain documentation that the untreated spices you purchase and send to the third-party (b)(4) providers are treated under a validated process that delivers an appropriate destruction of Salmonella.

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Penn State Food Safety Blog

DECEMBER 11, 2024

FDA issued a Warning Letter to Knickerbocker 365 Inc, a processor of ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located in Madison Heights, MI. In addition, the facilitys environmental testing document is not clear on the frequency of collecting environmental samples for pathogens, including Salmonella.

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Penn State Food Safety Blog

MARCH 13, 2024

FDA issued a Warning Letter to a Michigan firm after the firm failed to respond to FDA's request to provide corrective actions related to a recall the firm had conducted. The message here, respond to FDA requests. 343(w)], in that the finished product label fails to declare a major food allergen (milk). 331(uu)].

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Penn State Food Safety Blog

FEBRUARY 14, 2024

FDA issued a Warning Letter to an Indiana bakery that did not have proper label controls in place for sesame. FDA stated they will verify implementation of any corrective actions during FDA’s next inspection of the facility. 343(w)], in that the finished product label did not declare a major food allergen, sesame.

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Penn State Food Safety Blog

AUGUST 15, 2024

FDA issued a Warning Letter to the company that was responsible for producing the cinnamon apple sauce that was contaminated with lead. As you may remember, the cinnamon used had been contaminated with lead chromate in what FDA believed to be a case of economically-motivated intentional adulteration.

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Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a Chinese manufacture of RTE soy protein isolate. FDA inspected the food manufacturing facility, located in Ye County, Pingdingshan, Henan, 467200, China from August 15 to 17, 2023. Salmonella) as requiring a preventive control.' Yan Wang: The United States (U.S.)

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Penn State Food Safety Blog

MAY 22, 2024

In this Warning Letter issued to a cookie dough manufacturing company, it is important to see the approach FDA is taking with regard to allergens and supplier-controlled hazards. FDA responded, "However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions.

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Penn State Food Safety Blog

AUGUST 4, 2023

FDA issued a Warning Letter to a pretty small NJ Italian Food company who did not have a Food Safety Plan. There continues to be issues involving small food companies that have yet to address FSMA regulations. If FDA can find this place located in a neighborhood in Trenton.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Barsotti Juice Company, Inc. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations.

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Penn State Food Safety Blog

AUGUST 9, 2023

FDA issued a Warning Letter to STC India Private Limited, an Indian manufactuer of RTE mouth fresheners called Mukhwas. In the report, FDA cited Preventive Control issues, specifically around the control of pathogens in a RTE food, and GMP issues, including pest control and cleaning issues.

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Penn State Food Safety Blog

JULY 23, 2024

FDA issued a Warning Letter to Discover Fresh Foods, LLC of Greenville, SC, a manufacturer of refrigerated ready-to-eat (RTE) dips and spreads. FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for Listeria innocua (L. USDA FSIS notified FDA L. monocytogenes.

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Penn State Food Safety Blog

JUNE 12, 2024

FDA issued a Warning Letter to Midwest Foods, LLC, of Ankeny, IA. Failed to file scheduled process to FDA for some of the acidified foods Failed to follow scheduled process for some acidified products. Your significant violations are as follows: Acidified Foods Violations (21 CFR Part 108) 1. Ankeny Blvd.,

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Penn State Food Safety Blog

OCTOBER 25, 2024

FDA issues a Warning Letter to Alfred Louie Inc, a sprouting operation and noodle manufacturing facility, located in Bakersfield, CA. 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. For example: i.

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Penn State Food Safety Blog

APRIL 26, 2024

FDA issued a Warning Letter to Euro USA Inc seafood processing facility in Cleveland Ohio. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. In accordance with 21 CFR 123.6(g),

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Food Safety News

JANUARY 21, 2024

Business owners have 15 days to respond to FDA warning letters. 6, 2023 warning letter, the FDA described an April 17-21, 2023 inspection of Lone Star Botanicals Inc.’s s food manufacturing facility in Tyler, TX. After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.

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Food Safety News

FEBRUARY 16, 2024

NEW – Preventive Controls for Human Foods 2.0 – Kathy Gombas, Senior Advisor, FSMA Solutions and Martin Bucknavage, Senior Food Extension Associate and Team Lead, Industry Food Safety and Quality, Penn State will lead this new 2.5-day HACCP for Food Processing Personnel – This 20-hour class given over 2.5 day course.

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Penn State Food Safety Blog

JUNE 12, 2024

FDA issued a Warning Letter to Big Island Candies, Inc. of Hilo, HI after the company recalled their Big Island Candies Makana Brownie Assortment Box for not declaring the major food allergen, peanuts, finished product label. 343(w)], in that the finished product label did not declare the major food allergen, peanuts.

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Penn State Food Safety Blog

MARCH 8, 2024

FDA issued a Warning Letter to Gilster-Mary Lee Corporation of Chester, IL after they determined that the company's recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 343(w)], in that the finished product label did not declare a major food allergen, milk.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

FDA inspected a bottled water manufacturing facility located in Hilo, HI and issued a Warning Letter to that firm. 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. §

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a California bread company after the company had a recall for undeclared allergens. In the inspection, FDA found inadequate allergen controls. At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations.

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Penn State Food Safety Blog

DECEMBER 27, 2023

FDA issued a Warning Letter to US Gulf Coast Trading Co, a refrigerated, frozen, and ambient food product warehouse located at in Houston, TX. At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. I, Houston, TX on August 7 through 15, 2023.

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Food Quality & Safety

AUGUST 21, 2023

No one entity can protect food safety on its own. In FSMA, FDA clearly stated that the role of industry is to produce safe foods. FDA’s role is oversight in their jurisdiction, to ensure that industry is doing its job. At the federal level, FDA regulates food safety, including food processing, distribution, and labeling.

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Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a California Bakery. To make the long notice short [I really don't want to type this one out], the firm operated as if they had no knowledge of regulations. There was no food safety plan, and with that, no controls for allergens, environmental pathogens, etc. You do not have this program in place.

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Penn State Food Safety Blog

MARCH 27, 2024

FDA issued a Warning Letter to F1 Foods Inc, of Bridgewater, MA, a processor of ready-to-eat (RTE) prepared foods, including the processing of seafood and acidified food products. It seems this facility was operating as if not regulations exist. D/B/A Flavor First Foods Inc. D/B/A Flavor First Foods Inc.

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Penn State Food Safety Blog

JULY 12, 2024

FDA issued a Warning Letter to PepsiCo for their Quaker Oats manufacturing facility located in Danville, IL, a facility that manufactures RTE granola bars and RTE cereals. On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. FDA also collected environmental samples (i.e.,

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Penn State Food Safety Blog

DECEMBER 27, 2023

In a Warning Letter issued by FDA to a small KY desert company, Deserts by Hellen, FDA identified numerous GMP issues that demonstrate a lack of proper sanitary controls. FDA received your written response to the inspection via email on March 30, 2023, describing the corrective actions you have taken and plan to take.

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Penn State Food Safety Blog

JULY 1, 2024

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507. However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them.

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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. FDA Warning Letter [link] Living Tree Community Foods, Inc.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

FDA issued a Warning Letter to Lucky K.T. Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product. It is a huge Warning Letter, so in quick summary: Did not have a food safety plan with the required elements for any of the products manufactured at the facility. o FDA sample of Lucky K.T.

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Penn State Food Safety Blog

DECEMBER 27, 2023

FDA issued a Warning Letter to a NY Cheese processor. 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. Additionally, FDA collected environmental samples (i.e., Sweitzer and Ms.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a Colorado based RTE noodle company for not have a food safety plan in place, and with that any of the controls needed as part of that plan. 350d], and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR § 1.225 -1.245].

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

FDA issued a Warning Letter to Brewing Market Coffee, an acidified manufacturing facility located in Boulder, Colorado. 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,

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