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Annual Report to Congress on the Use of Mandatory Recall Authority - 2014
… other types of communications (e.g., consumer advisories, warning letters, and reports of outbreak investigations) that may … to October 24, 2013. On October 11, 2013, FDA issued a warning letter [6] to USPlabs, LLC informing the company that …
Annual Report to Congress on the Use of Mandatory Recall Authority - 2015
… other types of communications (e.g., consumer advisories, warning letters, and reports of outbreak investigations) that may …
Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
… The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for promoting and participating in …
Everything Health LLC - 613718 - 05/24/2021
… WARNING LETTER Date: May 24, 2021 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Predator Nutrition - 607136 - 10/23/2020
… WARNING LETTER Date: October 23, 2020 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Dr. Sherrill Sellman - 607964 - 06/01/2020
… WARNING LETTER Date: June 1, 2020 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary - 608906 - 11/10/2020
… WARNING LETTER Date: November 10, 2020 RE: Unapproved … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Color Additives History
… administrative, and judicial options which include warning letters, detentions, issuance of import alerts, and seizures. … the agency's Enforcement News page. FDA has recently sent warning letters for undeclared FD&C Yellow No. 6 in …
B4B Corp. - 609521 - 02/18/2021
… WARNING LETTER Date: February 18, 2021 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Red Moon Herbs - 607640 - 11/18/2020
… WARNING LETTER Date: November 18, 2020 … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
ChromaDex - 607692 - 11/17/2020
… WARNING LETTER Date: November 17, 2020 … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020
… The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 …
Color Additives
… Color additive violations are common reasons for warning letters and import detentions. Color additives are required …
Infant Formula
… an efficient and timely manner. The FDA also issued three warning letters to infant formula manufacturers in August 2023 to … and Response Activities January 9, 2023 FDA Issues Letters of Acknowledgement for Infant Formula Transition Plan …
Innovative Medicine LLC - 607721 - 11/17/2020
… WARNING LETTER Date: November 17, 2020 CC: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Living Tree Community Foods, Inc. - 656541 - 03/04/2024
… WARNING LETTER March 4, 2024 WL # 656541 Dear Mr. Schwartz: … #1 – Approved Supplier Program which includes Continuing Letters of Guarantee and Specifications” at the Receiving … . As you work to address the violations cited in this Warning Letter, we remind you that preventive controls, such …
La Parcela Produce LLC - 682277 - 07/16/2024
… July 16, 2024 WARNING LETTER Re: CMS # 682277 Dear Mr. Jose Jesus Garcia … 2024. Your response indicates you have “denied” and sent letters terminating your commercial relationship with foreign …
Aroma Imports, Inc. - 617818 - 12/23/2021
… December 23, 2021 WARNING LETTER Zachariah Zaid Mattan, President Re: CMS # … told the investigator that you were working on getting “letters of assurance” from your suppliers, but you did not …
Kuzmir Imports Inc. - 633082 - 08/02/2022
… WARNING LETTER Re: CMS # 633082 Dear Mr. Loeffler: From March … is safe for consumption, or what is included in the letters of guarantee. You also provided multiple certificates …
Kareem Mart Inc. - 613572 - 05/11/2021
… May 11, 2021 WARNING LETTER Re: CMS # 613572 Dear Mohamad Jamal Eddin: On … products imported from (b)(4) . You told us that you had letters of assurance from your (b)(4) located in the …
SafaLab, Inc. - 611233 - 02/18/2021
… WARNING LETTER Date: February 18, 2021 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Remarks by FDA Acting Commissioner Janet Woodcock to the FDLI Annual Conference - 05/18/2021
… products related to COVID-19. We’ve issued more than 170 warning letters to companies and individuals selling unproven … to understand supply chain problems, discover early warning signs of potential manufacturing discontinuances or …
ADM Animal Nutrition - 657846 - 10/23/2023
… WARNING LETTER CMS Case #657846 October 23, 2023 Dear Mr. … procedures for mycotoxin testing, your April 2023 response letters described actions you have taken or are planning to …
2012 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 …
Remarks by Dr. Sharpless at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds - 05/31/2019
… compounds in ways that violate the law. FDA has issued warning letters to companies selling unapproved CBD products. Our …