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). If you determine that S.

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FDA Food Safety Purchasing Food Regulations 86

FMT Magazine

MARCH 21, 2024

Apart from this, FSSAI officials discussed the importance of clean market places and establishment of health clubs in schools at the CAC meet and commissioners of Food Safety were also directed to develop 100 ‘Healthy and Hygienic Food Streets’ Encouragement for creating awareness about fortified rice and ensuring compliance with FSS (Fortification (..)

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Food Regulations Food Safety 52

FMT Magazine

FEBRUARY 28, 2024

The Indian food authority has asked the Commissioners of Food Safety of States and Directors of Regional Offices, to monitor the pendency of licensing applications under their jurisdiction through FoSCoS Dashboard and instruct the concerned licensing authorities to strictly adhere to the timelines as prescribed under clause 2.1.4

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Food Safety Food Regulations 52

FMT Magazine

FEBRUARY 28, 2024

The Indian food authority has asked the Commissioners of Food Safety of States and Directors of Regional Offices, to monitor the pendency of licensing applications under their jurisdiction through FoSCoS Dashboard and instruct the concerned licensing authorities to strictly adhere to the timelines as prescribed under clause 2.1.4

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Food Safety Food Regulations 52

Food Safety News

JANUARY 7, 2024

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. To sign up for a free subscription to Food Safety News, click here.)

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FDA Food Regulations Food Safety 110

Penn State Food Safety Blog

MAY 13, 2024

b)(2) The processing and production records for products failed to document the specific product variety, approximate number of containers per coding interval, initial product temperature, temperature-indicating device readings, and temperature recording device readings. Xia Wang Owner Hunan Gagazui Food Co., Xia Wang: The U.S.

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FDA Food Regulations Nutrition Food Safety 52

Food Safety News

MARCH 3, 2024

In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on March 21 and 28, 2023, you indicated that your firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation.

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FDA Food Regulations Food Operations 82

Penn State Food Safety Blog

AUGUST 15, 2024

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. The lemon peel was used in the manufacturing of Organic No Salt Blend, lot # 65724.

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FDA Food Safety Food Operations Purchasing 52

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". Cross Contact Controls (11.6)

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FDA Food Regulations 52

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)]. 343], as discussed below.

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FDA Nutrition Food Regulations Food Operations 52

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. Misbranding: Peanuts are considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. §

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FDA Food Operations Food Safety Food Regulations 52

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. However, you did not have a food safety plan with any of the required elements.

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FDA Food Safety Food Regulations Food Operations 52

Penn State Food Safety Blog

SEPTEMBER 5, 2024

Also, "the process controls did not include, as appropriate to the nature of the applicable control and its role in the facility's food safety system, parameters associated with the control of a hazard, as required by 21 CFR 117.135(c)(1)(i)" [link] Waiakea Bottling Inc.

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FDA Food Safety Food Operations Food Regulations 52

Penn State Food Safety Blog

APRIL 26, 2024

g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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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FDA Food Operations Food Regulations Food Safety 52

Penn State Food Safety Blog

FEBRUARY 14, 2024

On March 28, 2023, the company provided documents which indicated that they determined the root cause to be a “lack of label control,” as the receiver accepted incorrect packaging into the plant and the bagger operator used incorrect packaging that did not contain the correct allergen labeling.

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FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

MAY 22, 2024

FDA responded, "However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions. 343(w)], in that the finished product labels did not declare a major food allergen (peanuts). 343(w)], in that the finished product label fails to declare a major food allergen (peanuts).

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FDA Food Safety Food Regulations 52

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. 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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FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

MARCH 8, 2024

In addition, your firm has initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019. 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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FDA Food Operations Food Regulations 52

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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FDA Food Safety K-12 Food Operations 52

Penn State Food Safety Blog

JANUARY 11, 2024

Key among these, from my perspective, developing written procedures (SOPs) for the operation based upon reducing risk and then following these procedures with documentation. It seems that this was the biggest knock against the firm in this investigation.

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FDA Food Regulations 52

Penn State Food Safety Blog

MARCH 8, 2024

failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products 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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FDA Food Operations Food Storage 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. 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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FDA Nutrition Food Operations Food Regulations 52

Penn State Food Safety Blog

DECEMBER 27, 2023

During the inspection, the FDA investigator 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 Part CFR 117). To date, you have not submitted an attestation.

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FDA Equipment Maintenance Food Safety Food Operations 52

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).

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FDA Food Regulations Food Operations 52

Penn State Food Safety Blog

MARCH 27, 2024

You can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, the Seafood HACCP regulation, and the CGMP & PC rule through links on FDA’s home page at www.fda.gov. Your significant violations are as follows: Acidified Foods Violations (21 CFR Part 108 and 114): 1.

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FDA Food Regulations Equipment Maintenance Food Safety 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). Misbranding Violation: 3.

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FDA Nutrition Food Regulations Recipes 52

Penn State Food Safety Blog

JULY 23, 2024

During our inspection of your facility, our 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).

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FDA Food Safety Food Operations Food Regulations 52

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).

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FDA Food Regulations Food Operations Purchasing 52

Bill Marler

SEPTEMBER 2, 2021

Deputy Under Secretary for Food Safety. Food Safety and Inspection Service. Food Safety and Inspection Service. Designing Salmonella performance standard to more closely align with the goal of reducing foodborne illness is fundamental to improving food safety. August 19, 2021. Sandra Eskin.

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Food Safety Food Regulations FDA Hospitality 220

Food Safety News

JANUARY 21, 2024

s food manufacturing facility in Tyler, TX. The FDA’s inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation. The firm did not prepare, or have prepared, and implement a food safety plan. Specifically: a.

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Food Safety FDA Nutrition Food Regulations 92

Penn State Food Safety Blog

DECEMBER 27, 2023

During our inspection of your facility, 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).

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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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Food Safety FDA Food Operations Food Regulations 52

Food Safety News

OCTOBER 8, 2023

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. s food manufacturing facility in Los Angeles, CA. 16, 2023, documented that the air temperature was 39.0°F

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FDA Inventory Recipes Food Safety 126

Penn State Food Safety Blog

APRIL 3, 2024

([link] and found that they were not producing foods to the required food safety standards. Living Tree Community Foods, Inc, a Berkeley, CA processes organic seeds and tree nuts into ready to eat (RTE) organic seed and nut butters as well as repacks a variety of RTE and non RTE food products.

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Food Safety FDA Nutrition Food Operations 52

Penn State Food Safety Blog

AUGUST 15, 2024

General Enriquez, Tanicuchi Lote 8 171104 Quito, Pichincha Ecuador francisco@wanabanafruits.com Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States August 9, 2024 WARNING LETTER Reference #679052 Dear Mr. Peña: Beginning in October 2023, the U.S.

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FDA Food Safety Nutrition Food Regulations 52

Penn State Food Safety Blog

AUGUST 9, 2023

Road Dasihar-East Mumbai 400068 Maharashtra India bhavyashah@chandanmukhwas.com Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States July 21, 2023 WARNING LETTER Reference # 661775 Dear Mr. Shah: The United States (U.S.) It also does not appear that a (b)(4) step has been identified.

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FDA Food Safety Nutrition Food Regulations 52

Penn State Food Safety Blog

MAY 13, 2024

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. However, you did not have a food safety plan with any of the required elements.

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