Bill Marler

MARCH 29, 2022

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation.

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Penn State Food Safety Blog

NOVEMBER 4, 2024

The PACKAGED FOOD is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychotropic pathogens; Addressing food protection with new provisions that improve awareness of food defense measures; 2-103.11 Additional information on Food Defense is providing in Annex 2 4. Person in Charge.

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FDA Food Safety Food Preparation Food Regulations 52

Penn State Food Safety Blog

MAY 13, 2024

During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108), the Low Acid Canned Foods regulation (21 CFR Part 113). Your significant violations are as follows: 1. 03, 2024”.

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Penn State Food Safety Blog

MARCH 6, 2024

California has a Cannery Program that establishes requirements for California facilities that package both both low acid and acidified foods in sealed containers. link] How is this different than FDA Acidified or Low Acid Canned food regulations?

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Penn State Food Safety Blog

JUNE 12, 2024

The inspection determined there were significant violations of the Acidified Foods regulation [Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114)] and Emergency Permit Control regulation [Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)]. 21 CFR 101.9(c) c) and (d)]. b), Table 2.

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Food Safety News

FEBRUARY 26, 2024

Participants were surprised when told that food regulations could be devolved across the UK. This stemmed from a belief that food safety is unlikely to require national variation. Views toward regulatory divergence from EU legislation differed depending on attitudes toward the UK leaving the European Union.

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Food Safety News

SEPTEMBER 5, 2023

Here is an overview of each bill: SB 577 —Local Food Regulations and the Local Food Regulation Registry SB 577 provides clarity to food establishments and licensing authorities regarding the enforceability of health regulations.

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Bill Marler

APRIL 21, 2020

A criminal information filed today in federal court in Los Angeles charges Chipotle with adulterating food in violation of the Federal Food, Drug, and Cosmetic Act. The local health department found critical violations of local food regulations, including those specific to time and temperature controls for lettuce and beans.

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Bill Marler

SEPTEMBER 2, 2021

On June 5, 2020, we wrote former Under Secretary for Food Safety Mindy Brashears to supplement the Petition with additional and updated information, as well as to address some issues and criticism raised by comments submitted during the comment period, namely those generated using a template circulated by the Weston A.

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Food Safety News

MARCH 11, 2024

Those proposals deal with: additional oversight tools, such as expanding authorities for information-sharing with states, broadening authority to request records or other information in advance of or instead of inspections of all FDA-regulated commodities, and requiring importers to destroy products that present a significant public health concern, (..)

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Food Safety News

NOVEMBER 22, 2023

Resource issues in Kosovo Kosovo made some progress on food safety, veterinary and phytosanitary policy. A food control and traceability management system and the laboratory information management system for the food safety and veterinary laboratories were implemented.

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Bill Marler

DECEMBER 23, 2021

Of 14 people with information available, 12 have been hospitalized. In July 2018, approximately 647 people who dined at a Chipotle restaurant in Powell, Ohio reported illness related to Clostridium perfringens , a pathogen that grows rapidly when food is not held at appropriate temperatures.

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Penn State Food Safety Blog

JANUARY 11, 2024

Up-to-date information on outbreak-related activities and investigations can always be found on the CORE Investigation Table, FDA’s Public Health Advisories, Outbreak Investigation Reports, and Publications.

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Penn State Food Safety Blog

NOVEMBER 17, 2023

Foreign manufacturers must be in compliance with Preventive Controls for Human Foods regulations. For more information please see FDA’s Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food. FDA will update this advisory as information becomes available.

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Penn State Food Safety Blog

JUNE 12, 2024

The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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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. Chapter 12, Food Allergen Program, sets out to "is to explain how to establish and implement a food allergen program".

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Penn State Food Safety Blog

MAY 13, 2024

The also visually observed soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes.' 'The Additionally, your production manager informed the investigator that you use a vacuum for cleaning your post-lethal treatment direct food-contact surfaces in your packaging room.

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Kitchen CUT

NOVEMBER 17, 2021

The legislation was introduced to help the Food Hypersensitive Customer [FHS] make an informed decision when purchasing Grab and Go type foods [PPDS] after the tragic death of Natasha Ednan-Laperouse purchasing an unlabelled baguette containing sesame flour baked into the bread at a Pret a Manger site.

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Penn State Food Safety Blog

MARCH 27, 2024

It seems this facility was operating as if not regulations exist. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.

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Penn State Food Safety Blog

OCTOBER 25, 2024

Louie: The Food and Drug Administration (FDA) conducted an inspection of your sprouting operation and noodle manufacturing facility, located at 4501 Shepard St., 1 Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. Bakersfield, CA 93313 from January 2 through February 20, 2024.

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Penn State Food Safety Blog

MARCH 8, 2024

The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at www.fda.gov.

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FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

AUGUST 15, 2024

During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). We also address your response below.

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Penn State Food Safety Blog

SEPTEMBER 5, 2024

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. § Upon request, you provided a revised Food Safety Plan on April 3, 2024. We also address your responses below.

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Penn State Food Safety Blog

JULY 12, 2024

During the inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Chewy (b)(4)). Jackson Blvd.,

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Food Safety News

NOVEMBER 26, 2023

FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). You should provide this information in your response to this letter.

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FDA Food Safety Purchasing Food Regulations 122

Penn State Food Safety Blog

AUGUST 9, 2023

During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). We also address your responses below.

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Penn State Food Safety Blog

MARCH 13, 2024

Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117).

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FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

FEBRUARY 14, 2024

The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

MAY 20, 2024

Garcia: The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 681 Anita St, Ste 106, Chula Vista, CA 91911, from October 24 through November 28, 2023. 343(q)] in that the nutrition information (e.g., 379e(a)]. Your responses are addressed below as necessary. Your La Torta Bread (72 oz.),

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FDA Nutrition Food Operations Food Regulations 52

Penn State Food Safety Blog

JULY 1, 2024

During our inspection of your facility, the FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Specifically, a.

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Penn State Food Safety Blog

MAY 22, 2024

During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). We also address your response below.

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FDA Food Safety Food Regulations 52

Penn State Food Safety Blog

AUGUST 4, 2023

During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Food & Drug Administration, 10 Waterview Blvd.,

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FDA Food Safety Food Regulations Food Operations 52

Penn State Food Safety Blog

AUGUST 15, 2024

During the inspection of your facility, FDA investigators found serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117) and the Act.

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Food Quality & Safety

AUGUST 21, 2023

“Retail and food service establishments should now be aware of any ingredients that carry a potential risk of including this allergen,” Dr. Schaffner says. They should provide this information to customers by stating it on a product’s label, including a notification on a menu, or through other means.”

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Penn State Food Safety Blog

NOVEMBER 22, 2023

FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). You should provide this information in your response to this letter.

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Penn State Food Safety Blog

MAY 13, 2024

Kao: The United States Food and Drug Administration (FDA) inspected your manufacturing and distributing facility, located at 201 S Hill Dr, Brisbane, CA 94005, on August 14 through 31, 2023. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. We also address your response below.

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Penn State Food Safety Blog

DECEMBER 27, 2023

During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). We also address your responses below.

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