Search
Chicago Indoor Garden - 606992 - 12/29/2022
… of your firm’s corrective actions in response to our Warning Letters FY2020-HAFE-WL-04 and CHI-4-16. Based on our … you have addressed the violation(s) contained in these Warning Letters. Future FDA inspections and regulatory …
Muscle Sports Products, LLC - 625731 - 09/23/2022
… WARNING LETTER CMS # 625731 Dear Mr. Mancuso: This is to … produced salts (e.g., hordenine HCl). FDA recently sent warning letters to several firms selling dietary supplements …
E Vapor Hut LLC - 626435 - 07/01/2022
… an evaluation of your corrective actions included in your letters dated February 7, 2022, in response to our Warning Letter dated February 4, 2022. Based on our … that you have addressed the violation contained in the Warning Letter by no longer offering for sale e-liquids …
Pasha Food Distribution USA, Inc. - 607108 - 05/18/2020
… WARNING LETTER May 18, 2020 Re: CMS # 607108 Dear Mr. … very small importers because, while your response includes letters from your (b)(4) suppliers, these letters do not address the suppliers’ compliance with the …
Boehringer Ingelheim Animal Health USA - 674535 - 03/01/2024
… Senvelgo (velagliflozin oral solution) CMS #: 674535 WARNING LETTER Dear Mr. Legg: The U.S. Food and Drug … misleading promotional communication contradicts the boxed warning, contraindications, and approved indication of your … insulin.” 2 Senvelgo’s FDA-approved PI contains a boxed warning due to increased risk of diabetic ketoacidosis (DKA) …
The Ben Heggy Candy Company - 633394 - 09/23/2022
… September 23, 2022 Warning Letter 633394 Dear Mr. Wollenberg: The U.S. Food and … common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the …
Dollar Tree, Inc. - 629509 - 11/08/2022
… Additional Considerations Your corporation received a Warning Letter (320-20-07 1 sent to Greenbrier International … the Act, [21 U.S.C. § 331(c)]. Of particular concern, the Warning Letter detailed FDA evidence that Dollar Tree, parent … -compliance-enforcement-and-criminal-investigations/warning-letters/bicooya-cosmetics-limited-533477-08112017 … Center …
Herbal Amy Inc - 604813 - 03/06/2020
… WARNING LETTER Date: March 6, 2020 TO: amy@herbalamy.com – … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Todos Medical Ltd aka Todos Medical USA Inc - 626258 - 11/07/2022
… WARNING LETTER Date: November 7, 2022 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
AusarHerbs - 610976 - 01/12/2021
… WARNING LETTER Date: January 12, 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 …
Peterson Research Laboratories LLC - 607439 - 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 …
Beepothecary LLC - 608383 - 10/23/2020
… WARNING LETTER Date: October 23, 2020 TO: 3320 Toy Road … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Allimax Us - 609328 - 01/12/2021
… WARNING LETTER Date: January 12, 2021 RE: Unapproved … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group - 607197 - 08/10/2020
… WARNING LETTER Date: August 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 …
Beauty & Spa Concepts, DBA Beenefits - 613072 - 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 …
Mercola.com, LLC - 607133 - 02/18/2021
… WARNING LETTER Date: February 18, 2021 Cc: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
KetoKerri LLC - 605897 - 09/11/2020
… WARNING LETTER Date: 9/11/2020 Cc: Kerri Rivera 17544 College … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
FRS International, LLC - 606701 - 06/15/2020
… WARNING LETTER Date: June 15, 2020 … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Picket Fence Creamery LLC - 618726 - 01/14/2022
… January 14, 2022 FEI: 3005741975 Reference CMS #: 618726 WARNING LETTER Dear Mr. and Ms. Burkhart: The United States … Your product label only refers to the ingredient as “Dutch letters” and fails to list the sub-ingredients. Further, the …
Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. - 613803 - 07/28/2021
… WARNING LETTER Date: July 28, 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 …
Mario Hidalgo DBA Distribuidora de Productos Alimenticios El Paisita - 614478 - 07/12/2021
… WARNING LETTER July 12, 2021 Re: CMS # 614478 Dear Mr. Mario … last three years. You also stated that you were requesting letters from your small foreign suppliers asking them “to …
AMO and Wing Inc. dba T and H Trading Co. - 638293 - 12/07/2022
… WARNING LETTER December 7, 2022 Re: CMS # 638293 Dear Mr. … requested for an extension of thirty (30) days to obtain letters of assurance from your foreign suppliers. As of the …
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 …