Bill Marler

MAY 17, 2022

According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula. However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula.

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Nutrition FDA Food Safety 237

Bill Marler

MAY 14, 2022

This week the CDC declared an outbreak of Cronobacter infections over after the FDA received four complaints of Cronobacter infections in infants beginning on September 20, 2021, through January 11, 2022. Parents of all four infants reported having fed their children formula produced by Abbott Nutrition before they became ill.

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FDA Nutrition Staffing 189

Food Safety News

OCTOBER 8, 2023

Business owners have 15 days to respond to FDA warning letters. A food firm in California is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation. 7, 2023, warning letter, the FDA described a Feb. In a Sept.

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FDA Inventory Recipes Food Safety 126

Penn State Food Safety Blog

JULY 1, 2024

FDA along with USDA announced that they completed a study that confirms pasteurization is effective at inactivating Highly Pathogenic H5N1 Avian Influenza (H5N1 HPAI) virus in fluid milk and other dairy products made from pasteurized milk. Consumer Safety Officer, in the FDA’s Center for Food Safety and Applied Nutrition.

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Food Safety News

MARCH 5, 2024

The second bill, S08615/A9295 , would require companies to disclose to the state of New York when they add chemicals to foods and drinks that the company secretly self-determines are “generally recognized as safe” or GRAS , without notifying the FDA. These bills would introduce the most important reforms to the U.S.

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FDA Food and Beverage Food and Beverage Food Safety 132

The Food Law Firm

DECEMBER 20, 2023

A specification, also known as a “spec,” is a detailed document outlining the specific requirements and standards that a supplier must meet to provide raw materials, ingredients, or copacked products to a buyer. Objective language should always be used throughout the document.

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Recipes Nutrition Food Safety FDA 59

The Food Law Firm

DECEMBER 20, 2023

The “product specification” is the most critical document to a food business. A specification, also known as a “spec,” is a detailed document outlining the specific requirements and standards that a supplier must meet to provide raw materials, ingredients, or copacked products to a buyer.

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Recipes Nutrition Food Safety FDA 52

Penn State Food Safety Blog

OCTOBER 25, 2024

FDA issued a Warning Letter to a farm operation in Hawaii for violations from the Produce Safety Rule. Co-owner Bernardo Farms, LLC 15-3120 Pahoa Kapoho Rd Pahoa, HI 96778 United States Issuing Office: Center for Food Safety and Applied Nutrition United States WARNING LETTER CMS 686727 Dear Messrs. Bernardo: The U.S.

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FDA Nutrition Food Safety 52

Food Quality & Safety

JUNE 14, 2024

FDA has released new regulatory processes for intentional genomic alterations (IGAs) in animals, citing the need to update due to evolving science and innovations in animal biotechnology. For example, changes that result in faster growth may have an impact on the nutritional value of the food produced by these animals,” Schmidt says.

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FoodInsight

JULY 27, 2023

The IFIC 2023 Food and Health Survey found that 42% of consumers have encountered food or nutrition information on social media, and that of that subgroup, more than half (51%) have tried a new recipe and 41% have bought a new brand or product because of what they have seen promoted there. These GMO labels, required in the U.S.

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Nutrition Food and Beverage Food and Beverage Recipes 98

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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FDA Food Regulations Nutrition Food Safety 52

Food Quality & Safety

AUGUST 9, 2023

FDA and USDA both recently announced efforts to review label claims, with the goal of increasing consumer trust in and reliance on label claims. Front-of-pack labeling schemes that currently exist on the market are not enforced by FDA, nor are these schemes expressly permitted by FDA regulations. Product of the U.S.A.”

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FDA Nutrition Purchasing Food Safety 52

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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FDA Food Safety Nutrition Food Regulations 52

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.'

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FDA Food Safety Nutrition Food Regulations 52

Food Safety News

OCTOBER 2, 2023

Food and Drug Administration (FDA) has ruled cultivated meat is safe for human consumption. The FDA shares regulatory authority with the U.S. Experts from EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel), particularly its Novel Foods Working Group, will carry out these evaluations. “We

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Food Safety FDA Food Preparation Nutrition 86

Penn State Food Safety Blog

JULY 1, 2024

FDA issued a Warning Letter to Dollar Tree retailer for failing to stop selling the lead-contaminated cinnamon apple sauce after the recall was announced by WanaBana. FDA and state partners also collected and analyzed additional product samples of fruit puree and applesauce pouches. 331(c)].

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FDA Nutrition Food Safety Food Operations 52

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. 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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FDA Nutrition Food Regulations Food Operations 52

Penn State Food Safety Blog

SEPTEMBER 5, 2024

FDA issued a Warning Letter to a CA company selling goat milk for toddlers. Food and Drug Administration (FDA) conducted an inspection of your contract manufacturer’s facility located in (b)(4) from (b)(4) through (b)(4). You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

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FDA Food Operations Nutrition 52

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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FDA Food Safety Nutrition Food Regulations 52

Food Safety Tech

JULY 11, 2023

Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities.

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Penn State Food Safety Blog

APRIL 10, 2024

The back label containing the Nutrition Facts and Ingredients is incorrectly labeled as “Very Berry Strawberry”, in a 16oz round plastic deli cup. During routine documentation review the error was discovered by Quality Assurance. During routine documentation review the error was discovered by Quality Assurance.

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Food and Beverage Food and Beverage Nutrition FDA 52

Penn State Food Safety Blog

DECEMBER 13, 2023

While FDA cited the company for issues with its Preventive Controls Plan, FDA also hi on the company for failing to report the non-compliant product into the Reportable Food Registry. The Registry helps the FDA better protect the public health by tracking patterns and targeting inspections." Deverell, The U.S.

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Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to JX Restaurants, Inc located in Maryland Heights, MO a manufacturer of ready-to-eat (RTE) rice and noodle-based meals and RTE rice and noodle-based under USDA jurisdiction. And as proof to this point, FDA conducted swabbing and found Listiera. FDA also collected environmental samples (i.e.,

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FDA K-12 Food Safety Nutrition 52

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 After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations. Lone Star Botanicals Inc.

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Food Safety FDA Nutrition Food Regulations 92

Food Safety News

NOVEMBER 8, 2023

The event featured Dr. Eric Brown, from the Center for Food Safety and Applied Nutrition (CFSAN), at the U.S. FDA investigating a multistate outbreak of listeriosis linked to Blue Bell creameries products and a multistate outbreak of Listeria in Dole leafy greens products produced at a facility in Springfield, Ohio.

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Food Safety Nutrition FDA 62

Penn State Food Safety Blog

NOVEMBER 8, 2023

FDA issued a Warning Letter to ADM Animal Nutrition and their vitamin and mineral premix and preblend animal food manufacturing facility, located in Effingham, Illinois. 4 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

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FDA Nutrition Food Operations Inventory 52

Food Safety Tech

JUNE 4, 2024

This meticulous documentation not only facilitates supply chain management but also empowers swift actions such as recalls in the event of safety or quality breaches. Mislabelling involves incorrectly listing ingredients or nutritional information on labels. This not only cheats consumers but can also pose health risks.

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Food and Beverage Food and Beverage Food Supply FDA 64

Penn State Food Safety Blog

MAY 13, 2024

The FDA issued a Warning Letter after conducting a Foreign Regulatory Assessment (FRRA) of a seafood processing facility, located in Sevilla, Spain on October 2 through October 11, 2023. During that assessment, FDA found that the company had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

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Food Safety FDA Nutrition 52

Food Safety Tech

DECEMBER 4, 2024

Earlier this year, the FDA issued a warning to Bimbo Bakery for falsely listing allergens, including sesame, on its food labels in the US. The future of process management platforms Food businesses must consider using process management platforms in 2024 to not only ensure but also document that staff follow protocol stringently.

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Food Safety Recipes FDA Catering 52

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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FDA Nutrition Food Operations Food Regulations 52

Food Quality & Safety

APRIL 22, 2024

People increasingly want a balanced diet derived from safe, high quality ingredients for both their pets and human family members, and both types of foods are regulated by FDA. The nutritional needs of dogs and cats also differ. There have been several instances of recalls related to nutritional toxicities or deficiencies.”

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Food Safety Nutrition FDA 52

Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a California Bakery. You may find the Act and further information through links on FDA's website at [link] At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You do not have this program in place. Specifically, a.

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K-12 FDA Food Safety Nutrition 52

Penn State Food Safety Blog

APRIL 3, 2024

Recently, FDA inspected a Berkley California operation, Living Tree Community Foods, Inc. FDA Warning Letter [link] Living Tree Community Foods, Inc. At the conclusion of the inspection FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility. But is that enough?

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Food Safety FDA Nutrition Food Operations 52

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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Food Safety Tech

JULY 10, 2023

The FDA recently announced that it had no further questions about the safety of two cell-cultured meat products, which then went on to gain USDA grant of inspection and label approval. The FDA wants to know where that cell came from and also the stability—ensuring that cell is not going to change or modify over time.

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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. Specifically, no one in your facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.

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FDA Food Regulations Equipment Maintenance Food Safety 52

Food Safety News

SEPTEMBER 18, 2023

Late last year, the FDA gave cultivated meat maker California-based UPSIDE Foods the green light for its chicken grown from animal cells, marking the first regulatory approval for any cultivated meat in the United States. Are they healthy?

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