Penn State Food Safety Blog

NOVEMBER 22, 2023

Personal hygiene issues - did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required by 21 CFR 117.10(b).

FDA 86

FDA Food Safety Purchasing Food Regulations 86

Food Safety News

MARCH 3, 2024

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. 9, 2023, and March 20, 2023, were misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §

FDA 82

FDA Food Regulations Food Operations 82

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. link] Porfirios Italian Foods, Inc. Many may feel that they are flying under the radar.

FDA 52

FDA Food Safety Food Regulations Food Operations 52

Penn State Food Safety Blog

OCTOBER 27, 2023

Did not prepare, or have prepared, and did not implement a written food safety plan, as required by 21 CFR 507.31(a). MARCS-CMS 653966 — AUGUST 21, 2023. A sample of your medicated cattle feed labeled as “(b)(4)” for beef cattle was collected by FDA on January 27, 2023. Suther Feeds, Inc. Recipient: Dr. Michael P.

FDA 52

FDA Food Safety Inventory K-12 52

Penn State Food Safety Blog

AUGUST 15, 2024

The company did not conduct a reanalysis of your food safety plan when needed after Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)). Reno, NV, from November 27 through December 07, 2023, and January 03 through January 04, 2024. As examples: a.

FDA 52

FDA Food Safety Food Operations Purchasing 52

Penn State Food Safety Blog

JULY 1, 2024

From the Warning Letter, "On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s voluntary recall of Apple Cinnamon Fruit Puree pouches.

FDA 52

FDA Nutrition Food Safety Food Operations 52

Penn State Food Safety Blog

FEBRUARY 14, 2024

The firm recalled “Our Family” brand White Hot Dog Enriched Buns on March 21, 2023 after it was discovered that the product contained sesame, but the printed packaging did not declare sesame. The owner indicated that the firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation.

FDA 52

FDA Food Operations 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.

K-12 52

K-12 FDA Food Safety Nutrition 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.

FDA 52

FDA Food Safety Food Operations Food Regulations 52

Penn State Food Safety Blog

APRIL 26, 2024

O’Donnell: The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 4481 Johnston Parkway, Cleveland Ohio from July 10 to July 25, 2023. You provided a written response to the inspection on August 11, 2023, which included corrective actions taken by your firm.

FDA 52

FDA Food Operations Food Regulations Food Safety 52

Penn State Food Safety Blog

MARCH 13, 2024

A summary of the events: On September 12, 2023, the firm recalled Knickerbocker Homestyle Hamburger Buns after the firm discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. The message here, respond to FDA requests.

FDA 52

FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

NOVEMBER 8, 2023

Food and Drug Administration (FDA) conducted an inspection of your vitamin and mineral premix and preblend animal food manufacturing facility, located at 1200 McGrath Avenue, Effingham, Illinois 62401 on March 13 through March 16, 2023. We acknowledge your written responses dated April 6, 14, and 20, 2023.

FDA 52

FDA Nutrition Food Operations Inventory 52

Penn State Food Safety Blog

JULY 23, 2024

According to the report, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for L. monocytogenes isolates obtained from FDA environmental sample 124288 in 2023; four (4) L. monocytogenes. monocytogenes.

FDA 52

FDA Food Safety Food Operations Food Regulations 52

Penn State Food Safety Blog

MARCH 8, 2024

Findings: "HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). Your HACCP plan does not list the critical control points for each of the identified food hazards that is reasonably likely to occur as required per 21 CFR 120.8(b)(2).

FDA 52

FDA Food Storage Food Operations Food Regulations 52

Penn State Food Safety Blog

APRIL 26, 2024

[link] Appleton City Feed Service LLC MARCS-CMS 662279 — NOVEMBER 01, 2023 Recipient: Ms. 4th Street Appleton City, MO 64724-1406 United States Issuing Office: Division of Human and Animal Food Operations West II United States November 1, 2023 WARNING LETTER CMS # 662279 Dear Ms. Smith, The U.S.

FDA 52

FDA K-12 Food Safety Inventory 52

Penn State Food Safety Blog

DECEMBER 27, 2023

MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A. Friedman: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility located at 283 Thompson Avenue, Louisville, KY 40206 from February 27 through March 13, 2023. [link] Desserts by Helen, Inc.

FDA 52

FDA Equipment Maintenance Food Safety Food Operations 52

Penn State Food Safety Blog

MARCH 8, 2024

WARNING LETTER [link] Gilster-Mary Lee Corporation MARCS-CMS 658271 — AUGUST 28, 2023 Recipient: Mr. Thomas B. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §

FDA 52

FDA Food Operations Food Regulations 52

Penn State Food Safety Blog

SEPTEMBER 25, 2024

Fenton, MO 63026-4323 United States Issuing Office: Division of Human and Animal Food Operations West II United States WARNING LETTER March 21, 2024 CMS Case# 669917 Dear Mr. Zhou: The U.S. Food and Drug Administration (FDA) inspected your sprout operation, located at 1336 W. We address your responses below.

FDA 52

FDA Food Operations 52

Penn State Food Safety Blog

MARCH 27, 2024

On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan.

FDA 52

FDA Food Regulations Equipment Maintenance Food Safety 52

Penn State Food Safety Blog

JUNE 12, 2024

Elwell CEO/Owner United States Issuing Office: Division of Human and Animal Food Operations West II United States WARNING LETTER Reference #: CMS 677464 Date: May 21, 2024 Dear Mr. Elwell: The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility, located at 1802 N.

FDA 52

FDA Nutrition Food Regulations Food Operations 52

Penn State Food Safety Blog

FEBRUARY 14, 2024

Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product. It is a huge Warning Letter, so in quick summary: Did not have a food safety plan with the required elements for any of the products manufactured at the facility. FDA issued a Warning Letter to Lucky K.T. cereus and C.botulinum.

FDA 40

FDA Food Safety Nutrition Food Operations 40

Penn State Food Safety Blog

MAY 20, 2024

Most notably, one of these strains was identified in twenty-eight (28) isolates and matched four (4) clinical isolates (2017, 2018, 2019, and 2023), indicating that this strain is known to cause human illness, however, no epidemiological data was available to link the clinical isolate to your facility." Consuming foods contaminated with L.

FDA 52

FDA Food Operations 52

Penn State Food Safety Blog

DECEMBER 27, 2023

Cleaning Did not clean non-food contact surface in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination, Improper Storage Did not store food under conditions that protect against contamination of food, as required by 21 CFR § 117.93. 14100 Auto Park Way Ste.

FDA 52

FDA Food Regulations Food Operations 52

Penn State Food Safety Blog

JULY 12, 2024

This facility issued a recall of product for Salmonella in December of 2023. On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023. In April of 2024, the facility was closed.

FDA 52

FDA Food Regulations Food Operations Purchasing 52

Penn State Food Safety Blog

MARCH 8, 2024

Kraft Road West Saint Paul, MN 55118 United States Issuing Office: Division of Human and Animal Food Operations West I United States January 26, 2024 WARNING LETTER Refer to CMS 670835 Dear Mr. Palma: The U.S. 2 Furthermore, you are using the unapproved/unsafe animal food additive peroxyacetic acid (PAA). 342(a)(1). a)(1)(ii).

FDA 52

FDA K-12 Food Operations Food Safety 52

Penn State Food Safety Blog

FEBRUARY 19, 2024

In June of 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected Iowa Egg Company Inc.'s For example, from May 4, 2023, through June 4, 2023, the documented cooler temperatures ranged from 51°F to 68°Fconsecutively for 31 days." "Did 2010 Holmes Rd.

FDA 52

FDA Food Operations 52

Penn State Food Safety Blog

MAY 20, 2024

Your hazard analysis for your various bread products (part of your HACCP Plan dated November 2, 2023) identified allergens as a significant hazard requiring a Critical Control Point (CCP) at the packaging/labeling step. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No.

FDA 52

FDA Nutrition Food Operations Food Regulations 52

Penn State Food Safety Blog

MAY 20, 2024

FDA laboratory analysis of environmental sample 1216621 collected on August 9, 2023, from various areas in your processing facility during production found that eight (8) out of 111 swabs were confirmed positive for L. August 30, 2023, non-food contact environmental swabs collected from your facility." monocytogenes.

FDA 52

FDA K-12 Food Safety Nutrition 52

Penn State Food Safety Blog

SEPTEMBER 5, 2024

dba Sammy’s Milk 3471 Via Lido, Ste 207 Newport Beach, CA 92663 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER August 14, 2024 WL 682538 Dear Ms. Bracy Program Division Director Office of Human and Animal Food Operations - West Division 5 Hendricks: The U.S.

FDA 52

FDA Food Operations Nutrition 52

Penn State Food Safety Blog

AUGUST 30, 2024

This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. Food and Drug Administration (FDA) inspected your sprouting operation, located at 266 Forest Manor Road, Cochranville, Pennsylvania, from January 31, 2024, through March 12, 2024.

FDA 52

FDA Food Operations 52

Penn State Food Safety Blog

DECEMBER 27, 2023

During a June 2023 inspection of the facility, FDA found Listeria in the facility as well as identified many GMP issues related to cleaning and poor equipment. monocytogenes positive swabs was collected from the food contact surface of a cutting board that was being used to cut RTE Jersey Girl cheese. monocytogenes." monocytogenes."

FDA 40

FDA Food Operations Food Regulations Purchasing 40

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).

FDA 52

FDA Nutrition Food Regulations Recipes 52

Penn State Food Safety Blog

DECEMBER 13, 2023

[link] Nutra Blend, LLC subsidiary of Land O’Lakes MARCS-CMS 651174 — MAY 22, 2023 Product: Animal & Veterinary Drugs Food & Beverages Recipient: Ms. 4 Furthermore, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that it is reportable (i.e.,

FDA 52

FDA Food and Beverage Food and Beverage Nutritionist 52

Food Safety News

AUGUST 12, 2023

— OPINION — On July 29 the International Food Industry Think Tank discussed “Energizing Food Safety and Quality Assurance Transformation Process.” That discussion inspired the launching of the Safety, Security, and Quality Assurance (2S-QA) Movement on Aug. It calls for action to prevent future food-related tragedies.

Food Safety 65

Food Safety Food Supply Food Operations 65

Penn State Food Safety Blog

MAY 20, 2024

FDA issued a Warning Letter to a Colorado based RTE noodle company for not have a food safety plan in place, and with that any of the controls needed as part of that plan. Hopefully other noodle companies are noting the coming attention and are prepared with a well written Food Safety Plan. link] Ng Zheng Inc.

FDA 52

FDA Food Safety Food Operations Food Regulations 52

Penn State Food Safety Blog

SEPTEMBER 25, 2024

The company "failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. You may reach Ms.

FDA 52

FDA Food Regulations Food Safety Food Operations 52

Penn State Food Safety Blog

JULY 1, 2024

255 Business Center Drive Horsham, PA 19044 United States tony.gavin@grupobimbo.com Issuing Office: Division of Human and Animal Food Operations West IV United States June 17, 2024 WARNING LETTER Ref: CMS Case #672140 Dear Mr. Gavin: This is to advise you that the U.S. You may reach Ms. Sincerely, /S/ E.

FDA 52

FDA Nutrition Food Operations 52