Creative Science, Inc. - 554119 - 10/08/2019

… We received your July 3, 2018, and August 16, 2018, letters and August 22, 2019, and September 6, 2019, email communications in response to Warning Letter Case# 554119. Your letters and email … evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that you …

Med Shop Total Care, Inc. - 581309 - 10/11/2023

… of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case … adequately addressed the violations contained in these warning letters. You are expected to take all necessary steps …

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) …

Evanger's Dog & Cat Food Co - 518544 - 06/29/2017

… IL 60661 Telephone: (312) 353-5863 Fax: 312) 596-4187   WARNING LETTER FY17-HAFE6-01   June 29, 2017   UPS NEXT DAY … all current and new suppliers must provide Evanger’s with letters of guarantee for their products. FDA has concerns …