Penn State Food Safety Blog

MAY 13, 2024

FDA issued a Warning Letter to a low acid canned food (LACF) facility, located on Huarong County, Yueyang, Hunan, China. Did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35 Xia Wang: The U.S. Your significant violations are as follows: 1.

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Penn State Food Safety Blog

AUGUST 9, 2023

FDA Warning Letter [link] STC India Private Limited MARCS-CMS 661775 — JULY 21, 2023 Recipient: Mr. Bhavya P. We received your additional response on February 5, 2023 which included your revised product labels. Your February 2 response included a revised Food Safety Plan and Preventive Control Plan dated January 19, 2023.

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Penn State Food Safety Blog

APRIL 3, 2024

In the company response dated April 28, 2023, the company provided a revised “Approved Supplier Program Version 3.” Your firm manufactures 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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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. the listing regulation for FD&C Yellow No. In the inspection, FDA found inadequate allergen controls.

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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.

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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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Penn State Food Safety Blog

MAY 13, 2024

The inspection revealed significant violations of 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). As a result, your firm recalled these products on September 1, 2023.

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Penn State Food Safety Blog

MAY 13, 2024

FDA inspected the food manufacturing facility, located in Ye County, Pingdingshan, Henan, 467200, China from August 15 to 17, 2023. Soy protein isolate is used as a protein source in a number of food items including as an ingredient in smoothie mixes, pancake mixes, and breakfast ceral. Sincerely, /S/ Ann M. Oxenham, J.D.

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Penn State Food Safety Blog

FEBRUARY 14, 2024

Thong: The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 10925 Schmidt Rd, El Monte, CA 91733 on April 18, 2023, through May 11, 2023. You provided a response to the FDA 483 dated June 2, 2023, describing corrective actions taken by your firm.

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Penn State Food Safety Blog

JULY 1, 2024

Keenan: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility, located at 1212 Reading Road, Bowmansville, PA, 17507, from September 18 through October 3, 2023. 343(q)] in that the nutrition facts information is not as defined in 21 CFR § 101.9.

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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. Yapoujian: The U.S.

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