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FDA is Committed to Sound, Science-based Policy on CBD
… Over the past several years, the Agency has issued several warning letters to firms that were marketing unapproved new drugs …
Mexpobaja Corporation - 670016 - 01/23/2024
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/mexpobaja-corporation-670016-01232024 … WARNING LETTER 01/23/2024 Re: CMS # 670016 Dear Mr. Ibarra, …
2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
… example, in 2011, FDA and FTC issued seven jointly-signed warning letters to companies marketing over-the-counter weight loss products. In 2010, both FDA and FTC issued warning letters to POM Wonderful over marketing of their POM …
FY18/19 Sample Collection and Analysis of Domestically Manufactured, Dairy-Free Dark Chocolate Products for Milk Allergen
… Regulatory tools at the agency’s disposal include warning letters, seizures, injunctions, and mandatory recalls (if a …
Consumer Health Information for Better Nutrition Initiative - Attachment I - Public Docket Comments
… through the addition of a disclaimer, qualification, or warning statement. it must be&. . . Viewed from the vantage … federal courts define disclaimers, qualifications, and warning statements as the only means available to the … AMA has communicated its concerns to the FDA in numerous letters over the past four years and has testified before …
Suntraco Food Industries SDN BHD - 545371 - 02/08/2018
… -compliance-enforcement-and-criminal-investigations/warning-letters/suntraco-food-industries-sdn-bhd-545371-02082018 … WARNING LETTER FEB 8, 2018 VIA EXPRESS DELIVERY Mr. Tang Hang … and clarification regarding your scheduled processes. Letters were sent to your firm on August 11, 2016 for your …
Pop Daddy Popcorn, LLC - 646807 - 03/28/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/pop-daddy-popcorn-llc-646807-03282023 … WARNING LETTER FY23-HAFE6-03 CMS 646807 03/28/2023 Dear Mr. …
21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020
… … WARNING LETTER Date: July 21, 2020 TO: 41990 Cook Street … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products
… activities. For example, in connection with several warning letters sent to firms for marketing unapproved new drugs that …
Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and Transporters
… federal government's focal point for threat assessment, warning, investigation, and response for threats or attacks … the NIPC identifies credible threats and crafts specific warning messages to the food industry. Further information is … that are contained in purchase and shipping contracts or letters of credit, or using a vendor approval program) …
Speech by Commissioner Robert M. Califf to the House of Medicine - 06/16/2023
… require decisions or complex actions like recalls or warning letters on tobacco, we routinely consider the opportunity for …
Bakkavor Foods USA Inc. - 630545 - 08/08/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/bakkavor-foods-usa-inc-630545-08082022 … August 08, 2022 RE: CMS #: 630545 WARNING LETTER Dear Mr. Anchirayco: The United States Food …
Small Entity Compliance Guide: Juice HACCP
… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 55. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …
Frequently Asked Questions: FSMA Food Traceability Rule
… an enforcement action. We may issue advisory action letters, which include Untitled Letters and Warning Letters, to notify firms of violations and to prompt … issue advisory action letters, which include Untitled and Warning Letters, to notify firms of violations and to prompt …
Progress Update on FDA’s Evaluation of the Infant Formula Response
… the powdered infant formula industry. The FDA issued warning letters to three infant formula firms for inspection findings …
Transcript of Introductory Video on Fish and Fishery Products Hazards and Controls Guidance, 4th Edition
… Establishments when notified that FDA has issued a warning letter or intends to take regulatory action such as … FDA intends to take regulatory action, including issuing warning letters, to a fish or fishery product establishment currently …
Western Herb Products, Inc. - 615439 - 12/07/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/western-herb-products-inc-615439-12072021 … December 7, 2021 In reply, refer to CMS 615439 WARNING LETTER Dear Dr. Summerland: The United States Food …
Guidance for Industry: Questions and Answers on Juice HACCP Regulation
… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 63. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …
CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
… FDA may elect to refuse prior notices or send Compliance letters to give the responsible parties warning prior to pursuing other regulatory actions, e.g., …
Bea Lydecker’s Naturals, Inc. - 616439 - 02/09/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/bea-lydeckers-naturals-inc-616439-02092022 … February 9, 2022 In reply, refer to CMS 616439 WARNING LETTER Dear Ms. Lydecker-Hayford: The U.S. Food and …
Kingdom Harvest - 625058 - 05/04/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/kingdom-harvest-625058-05042022 … WARNING LETTER May 4, 2022 RE: # 625058 Dear Ms. Rogers: This …
Potential for Infiltration, Survival, and Growth of Human Pathogens within Fruits and Vegetables
… most resistant pathogen of public health concern) bear a warning statement informing consumers of the potential risk … phosphate for killing Salmonella montevideo on tomatoes. Letters Appl. Microbiol. 22:97-100. Zhuang, R.Y., Beuchat, …
FDA's Responses to Public Comments on the Draft Report "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food"
… during a 60-day period, ending August 16, 2005. Eighteen letters were received, including comments from consumer …
National Drug Residue Milk Monitoring Program
… sanctions such as injunction, prosecution, seizure and warning letters are available. Compliance Policy Guide 7125.05 offers …
Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition
… labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable juice … HACCP regulation such as effective dates, use of the label warning statement, and training. Additional information on … individuals. 6 In the January 22, and January 25, 2002 letters, FDA described high degree Brix juice concentrate as …