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).

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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. Your significant violations are as follows: 1.

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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". Cross Contact Controls (11.6)

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FMT Magazine

FEBRUARY 28, 2024

The food regulator added that, once an application is marked for inspection in non-mandatory categories, inspection should be done within 15 days. And, in case, inspection is not conducted within 15 days, DO should recall the application back to Document Scrutiny Stage in FoSCoS and grant the licence.

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FMT Magazine

FEBRUARY 28, 2024

The food regulator added that, once an application is marked for inspection in non-mandatory categories, inspection should be done within 15 days. And, in case, inspection is not conducted within 15 days, DO should recall the application back to Document Scrutiny Stage in FoSCoS and grant the licence.

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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)]. 343], as discussed below.

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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

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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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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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. These violations include the presence of rodents, maggots and more. 5, 2023, warning letter, the FDA described an Aug.

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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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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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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.

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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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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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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).

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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. § We cannot fully evaluate this response because you did not provide for our review any documentation to evaluate this corrective action.

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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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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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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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Penn State Food Safety Blog

AUGUST 4, 2023

This is such a case where this small Italian food company did not have a food safety plan, and along with that, did not have documented controls in place for allergens among other potential hazards. Many may feel that they are flying under the radar. Here is a pic taken from a Google search of the address.

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Food Quality & Safety

AUGUST 21, 2023

Government agencies and news outlets often share food recall and outbreak information on their social media platforms. Verify that suppliers meet food safety standards and request relevant documentation, such as a Certificates of Analysis,” Fink adds, if that’s applicable to the type of business involved.

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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).

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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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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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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

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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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

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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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. § 1400 Independence Avenue, SW. Mailstop 3782. Washington, D.C. 601(m)(1) and 21 U.S.C. §

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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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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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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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Penn State Food Safety Blog

MAY 13, 2024

Further, after employees completed and documented cleaning of the packing room, the investigator visually observed apparent soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes. Salmonella) as requiring a preventive control.'

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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).

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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. 6, 2023 warning letter, the FDA described an April 17-21, 2023 inspection of Lone Star Botanicals Inc.’s

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Penn State Food Safety Blog

SEPTEMBER 25, 2024

The inspection and our sample analysis revealed serious deviations from the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and Acidified Foods regulations, Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114).

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