Food Safety Tech

NOVEMBER 15, 2024

FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This guidance document is presented in question and answer format.

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FDA Food Safety 75

Bill Marler

MAY 21, 2022

Also in 2009, the US Food and Drug Administration (FDA) issued two sets of recommendations for reducing the risk of Salmonella contamination in peanut products, one aimed at the food industry and the other at food service establishments and retail stores. The FDA published the documents on its Web site.

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FDA Food Safety Food Service Food Service 184

Bill Marler

APRIL 30, 2022

How confident should we feel with this waring from the FDA: “those seeking access [to the formula] should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.”.

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FDA Nutrition 210

Food Safety News

JANUARY 28, 2024

Business owners have 15 days to respond to FDA warning letters. Santa Monica, CA A California food firm with a facility in Maryland is on notice from the FDA for unsanitary storing of ingredients that could contaminate food products. After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.

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FDA Food Safety 138

Bill Marler

APRIL 28, 2022

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1). The disclosure document was sent to top food safety officials and other leaders at FDA in October 2021. The document was apparently not sent to FDA’s deputy director for food safety concerns, Frank Yiannas.

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Food Safety Nutrition FDA Staffing 268

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. Congress is set to hopefully get responses from the FDA to these questions in a hearing scheduled for May 25 th.

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FDA Nutrition Staffing 189

Food Safety News

SEPTEMBER 28, 2023

The FDA has released its final food safety guidance for producers of sprouts, a food that has been linked to several outbreaks in recent years. The Food and Drug Administration has also released a revised draft of a second guidance document that includes a section on testing spent sprout irrigation water for pathogens.

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FDA Food Safety Hospitality Hospitality 122

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

Modern Restaurant Management

APRIL 27, 2020

The document is meant to be used in conjunction with instruction operators receive from authorities during their reopening phase-in. The National Restaurant Association partnered with representatives of the FDA, academia, the Conference for Food Protection, Ecolab, public health officials and industry representatives to develop the guidance.

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FDA Point of Sale Restaurant Manager Restaurant Management 231

Bill Marler

NOVEMBER 4, 2023

The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm and on October 31, 2023, Wanabana LLC initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches.

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FDA 166

Bill Marler

SEPTEMBER 22, 2020

From FDA Press Release from yesterday: Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “ Food Traceability List ,” which describes the foods that would be subject to the proposed requirements.

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Food Safety FDA 157

Food Safety News

FEBRUARY 13, 2024

Food and Drug Administration (FDA) is responsible for ensuring that the nation’s domestic and imported seafood supply is safe, sanitary, wholesome, and honestly labeled. The agency recently provided access to content about seafood, including fish and shellfish, from across the Food section of FDA.gov.

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FDA Food Safety 100

Food Safety Tech

NOVEMBER 14, 2023

The FDA has updated the CFSAN Online Submission Module (COSM) to improve communication for industry who send regulatory submissions to FDA’s Office of Food Additive Safety (OFAS). The form then guides users through developing and organizing the documents in the appropriate order for submission directly to OFAS.

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FDA 111

Bill Marler

MAY 10, 2022

These illnesses were ultimately linked by the CDC and FDA to the consumption of powdered infant formula produced by Abbott in its Sturgis, Michigan facility. So, how did Abbott and the FDA find themselves facing some grieving and many other thousands of scared and angry parents? It is a history of warning signs ignored.

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FDA Food Safety 223

Food Safety News

NOVEMBER 26, 2023

Business owners have 15 days to respond to FDA warning letters. The FDA inspected your manufacturing facility, located at 10849 Midwest Industrial Blvd. The FDA inspected your manufacturing facility, located at 10849 Midwest Industrial Blvd. Louis, MO In a Nov. 9 warning letter to Wan-Gee Foods Inc.

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FDA Food Safety Purchasing Food Regulations 122

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

Food Safety Tech

FEBRUARY 12, 2024

Food and Drug Administration (FDA) has issued a draft guidance for industry titled “ Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.”

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FDA 105

Food Safety Tech

FEBRUARY 5, 2024

The FDA is withdrawing a 2022 guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry , following a decision by the U.S.

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FDA 105

Food Safety News

NOVEMBER 19, 2023

Business owners have 15 days to respond to FDA warning letters. Golden Natural Products Forest Hills, NY An import company in New York is on notice from the FDA for not having a Foreign Supplier Verification Program (FSVP) for a number of imported food products. In an Oct. American Distribution and Manufacturing Co.,

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FDA Food Safety 105

Bill Marler

MAY 24, 2022

Now the House and Senate are set to ask questions of the Industry and FDA about how the outbreak happened and how it impacted the supply of infant formula. Here is a preview of the FDA’s position See full testimony – FDA Testimony ECOI Infant Formula 5.25.2022 final : TESTIMONY OF. CALIFF, M.D. COMMISSIONER OF FOOD AND DRUGS.

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Nutrition FDA Purchasing Food Supply 300

Food Safety News

NOVEMBER 5, 2023

The FDA concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans. It keeps citrus flavorings from coming apart and rising to the top of the beverage.

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FDA Food and Beverage Food and Beverage Food Safety 114

Food Safety Tech

OCTOBER 3, 2023

The FDA has released two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. FDA-2016-D-2343). Comments should be submitted within 180 days of September 26, 2023, to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

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FDA Food Regulations 104

Penn State Food Safety Blog

FEBRUARY 1, 2024

FDA issued the updated Appendix 1 of their Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry document. The document can be found here. The second document released today is a revised draft of Appendix 1 “Known or reasonably foreseeable hazards (“potential hazards”).”

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FDA Food Safety 52

Food Safety News

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) are not uncommon where Kratom is involved. The tropical tree native to Southeast Asia is not approved for any medical use by the FDA but is often mentioned for one kind of caution or another. FDA has not approved kratom for sale in the U.S., Import alerts, warning letters, and seizures by U.S.

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FDA Food Safety Purchasing 111

Food Safety News

AUGUST 27, 2023

Business owners have 15 days to respond to FDA warning letters. Eco Food Distribution LLC Schiller Park, IL An import company in Illinois is on notice from the FDA for not developing an FSVP for the foods they import. In a May 25 warning letter, the FDA described a Feb. In a May 25 warning letter, the FDA described a Feb.

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FDA Food Safety 86

Food Safety News

NOVEMBER 5, 2023

Business owners have 15 days to respond to FDA warning letters. During the most recent inspection, the FDA found that the company is not in compliance with the requirements of 21 CFR part 1, subpart L for the foods it imports. The FDA has acknowledged receipt of the company’s written response, dated May 2, 2023.

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FDA Food Safety 82

Bill Marler

JANUARY 24, 2021

KING: Bill, is it true that there’s a bill in Congress that the FDA, if passed, could clamp down on things that David just described? MARLER: Well, whether or not the FDA would clamp down on that is I think to be seen. Clearly, the FDA does not have the sort of authority that it needs to protect the U.S. COMMERCIAL BREAK).

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FDA Food Safety Purchasing Hospitality 325

Bill Marler

DECEMBER 27, 2019

According to the FDA , Sprouts Unlimited of Marion Iowa is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria ( E. In an effort to reduce these outbreaks, the FDA in 2017 collected 825 samples of sprouts from across the U.S.; coli O103 ). with a blue label on the lid.

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Food Safety FDA Hospitality Hospitality 191

Penn State Food Safety Blog

NOVEMBER 22, 2023

FDA issued a Warning Letter to Wan-Gee Foods of St. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 10849 Midwest Industrial Blvd. At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations.

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FDA Food Safety Purchasing Food Regulations 86

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. The FDA will continue to work in closely partnership with USDA on many of these efforts.

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FDA Nutrition Food Safety 96

Food Safety News

MARCH 3, 2024

Business owners have 15 days to respond to FDA warning letters. 7, 2023 warning letter, the FDA told the bakery owner that the agency has determined that your recalled “Our Family” brand White Hot Dog Enriched Buns (8 count, 12oz. Some letters are not posted for public view until weeks or months after they are sent.

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FDA Food Regulations Food Operations 82

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

Bill Marler

DECEMBER 10, 2021

4] However, three months later, at a meeting with the FDA, Jimmy John’s Franchise, LLC changed its position and stated that it would serve only clover sprouts sourced from specific suppliers. [5]. the owner of Jimmy John’s, LLC, replied to the FDA that sprouts had been permanently removed from the menu at all Jimmy John’s locations.

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FDA Purchasing Food Safety Hospitality 209

Food Safety Magazine

JANUARY 6, 2025

FDA has released four new guidance documents to help industry comply with food labeling regulations concerning allergens and plant-based alternatives to animal foods, as well as food safety regulations for ready-to-eat (RTE), low-moisture foods.

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Food Safety FDA Food Safety Regulations 52

SQF Institute

APRIL 28, 2023

Food and Drug Administration (FDA) issued the Food Traceability Rule to quickly identify and mitigate risk associated with “high risk” foods prone to contamination. The complexity of FDA’s mandate impacts more than 10,000 products and puts an unnecessary paperwork burden on the food supply chain.

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FDA Food Supply 52

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. Yet, it is still allowed to be used in food and oral drugs.

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FDA Food and Beverage Food and Beverage Food Safety 132

Food Safety Tech

AUGUST 15, 2024

According to ISO definition, an audit is “systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” An inspection is the “determination of conformity to specific requirements,” such as FDA or USDA regulations.

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Food Safety FDA Food Supply Hospitality 114