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Elwell CEO/Owner United States Issuing Office: Division of Human and Animal FoodOperations 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 issued a Warning Letter to ADM Animal Nutrition and their vitamin and mineral premix and preblend animal food manufacturing facility, located in Effingham, Illinois. 2 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.3
The Food and Drug Administration is requesting 7.4 1, 2023, and runs through Sept. Problems with inspections related to imported food came to light in the fall of 2023 when it was discovered that cinnamon applesauce marketed for children in the United States and imported from Ecuador was contaminated with lead.
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.
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.
dba Sammy’s Milk 3471 Via Lido, Ste 207 Newport Beach, CA 92663 United States Issuing Office: Division of Human and Animal FoodOperations West V United States WARNING LETTER August 14, 2024 WL 682538 Dear Ms. Sammy’s Milk is safe [sic] we meet every FDA nutritional & manufacturing requirement for infant formula.
The internet has opened the door to many foodoperations to sell products. Recently, FDA inspected a Berkley California operation, Living Tree Community Foods, Inc. link] and found that they were not producing foods to the required food safety standards. But is that enough?
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.
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.
During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). You do not have this program in place.
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.
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.
[link] Nutra Blend, LLC subsidiary of Land O’Lakes MARCS-CMS 651174 — MAY 22, 2023 Product: Animal & Veterinary Drugs Food & Beverages Recipient: Ms. Lisa Deverell President, Purina Animal Nutrition; Executive Vice President, Land O’ Lakes, Inc. 5 Failure to submit a required reportable food report is a prohibited act.6
255 Business Center Drive Horsham, PA 19044 United States tony.gavin@grupobimbo.com Issuing Office: Division of Human and Animal FoodOperations 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. According to 21 CFR § 101.22(a)(3), According to 21 CFR § 101.22(a)(3),
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.
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