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The inspection determined there were significant violations of the Acidified Foodsregulation [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. 21 CFR 101.9(c)
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. Xia Wang Owner Hunan Gagazui Food Co., Xia Wang: The U.S.
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. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9.
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 Foodregulation (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Misbranding Violation: 3. Specifically, a.
You can find the Act, the Emergency Permit Control regulation, the Acidified Foodregulation, 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.
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 Foodregulation. s food manufacturing facility in Los Angeles, CA. 16, 2023, documented that the air temperature was 39.0°F
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. Sincerely, /S/ Ann M. Oxenham, J.D.
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 Foodregulation. Nutrition Facts label, “NFL”) is not in accordance with the requirements.
Road Dasihar-East Mumbai 400068 Maharashtra India bhavyashah@chandanmukhwas.com Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States July 21, 2023 WARNING LETTER Reference # 661775 Dear Mr. Shah: The United States (U.S.) If you have any questions regarding this letter, you may contact Mr.
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.'
Kao: The United States Food and Drug Administration (FDA) inspected your manufacturing and distributing facility, located at 201 S Hill Dr, Brisbane, CA 94005, on August 14 through 31, 2023. You do not perform and document the review of labels for proper declaration of allergens. 379e(a)]. . §
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 Foodsregulations, Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114).
During our inspection of your facility, the FDA investigators found 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). c)(8)(ii), 21 CFR 101.9(c)(7)(i),
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). Specifically, the following were observed: a.
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