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MARCS-CMS 660360 — NOVEMBER 09, 2023 Recipient: Samson Wang CEO/President Wan-Gee Foods, Inc. Louis, MO 63132 United States Issuing Office: Division of Human and Animal FoodOperations West II United States November 9, 2023 FEI: 1000138918 CMS Case No.: 10849 Midwest Industrial Blvd. 660360 WARNING LETTER Dear Mr. Wang: The U.S.
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. Bracy Program Division Director Office of Human and Animal FoodOperations – West Division 5 12101 Moya Blvd.
Bakersfield, CA 93313 United States Issuing Office: Division of Human and Animal FoodOperations West V United States WARNING LETTER September 11, 2024 WL 680624 Dear Messrs. Louie: The Food and Drug Administration (FDA) conducted an inspection of your sprouting operation and noodle manufacturing facility, located at 4501 Shepard St.,
The internet has opened the door to many foodoperations to sell products. People often base their decision for purchasing based upon that website. Recently, FDA inspected a Berkley California operation, Living Tree Community Foods, Inc. Unfortunately, there is little more to go on than that. But is that enough?
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 Foodregulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Sharon Tomaselli Co-Owners Cooperstown Cheese Company, LLC 107 Oxbow Road Milford, NY 13807-1131 United States Issuing Office: Division of Human and Animal FoodOperations East I United States WARNING LETTER CMS # 667551 11/24/2023 Dear Mr. Sweitzer and Ms. Sweitzer and Ms. Milford, NY 13807-1131 from June 21 through July 28, 2023.
During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Foodregulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Thong Manager Lucky K.T. Sincerely, /S/ Darla R.
Zheng: The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 1140 W Louisiana Avenue, Denver, Colorado from September 18, 2023 to October 23, 2023. Food and Drug Administration; Attn: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov or at 6th Ave and Kipling St, DFC Bldg.
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