GOJO Industries Inc - 599132 - 11/30/2020

… the corrective actions your firm made in response to our Warning Letter #599132 issued January 17, 2020. We … your February 7, 2020, February 26, 2020, and June 5, 2020 letters that detail the corrective actions that GOJO … to prevent a reoccurrence of the violations noted in the Warning Letter. As a reminder, the January 17, 2020 Warning …

HNC Products Inc. - 607359 - 02/02/2023

… March 19, 2021; April 23, 2021; and February 16, 2022, letters in response to Warning Letter #607359. Your letters have been made a part of … evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that you …

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. - 628182 - 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 …

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 …

Auro Pharmacies, Inc. - 608369 - 04/11/2023

… of your firm’s corrective actions in response to our warning letters (WL 8-17 dated December 13, 2016, and WL CMS 608369 … have adequately addressed the violations contained in the warning letters. You are expected to take all necessary steps …

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 …

Dexcowin Co. Ltd. - 545388 - 10/25/2023

… of your firm’s corrective actions in response to our Warning Letters (CMS Case No. 545388, dated February 20, 2018, and … that you have addressed the violations contained in these Warning Letters. Future FDA inspections and regulatory …

Formulife, Inc. - 508605 - 03/02/2018

… of your firm's corrective actions in response to our Warning Letters (2012-DAL-WL-12, January 18, 2012; 2013-DAL-WL-38, … that you have addressed the violations contained in these Warning Letters. Future FDA inspections and regulatory …

RightEye, LLC - 643192 - 12/20/2022

… WARNING LETTER CMS# 643192 December 20, 2022 Dear Mr. Gross: … firm’s responses and concluded they are not adequate. Your letters indicated that a full assessment of your Quality … comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in …

Olympus Medical Systems Corporation - 546986 - 03/09/2018

…     10903 New Hampshire Avenue Silver Spring, MD 20993    WARNING LETTER       VIA UNITED PARCEL SERVICE   March 9, … States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Olympus Corporation of the … firm separately in advisories included in the decision letters for the interim reports.   The 522 Order recommends …

Fujifilm - 546987 - 03/09/2018

…     10903 New Hampshire Avenue Silver Spring, MD 20993    WARNING LETTER       VIA UNITED PARCEL SERVICE   March 9, … States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Fujifilm Medical System … firm separately in advisories included in the decision letters for the interim reports.    The 522 Order recommends …

Hoya Corporation - 546991 - Pentax Life Division

…     10903 New Hampshire Avenue Silver Spring, MD 20993    WARNING LETTER       VIA UNITED PARCEL SERVICE   March 9, … States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Pentax of America, Inc.’s … firm separately in advisories included in the decision letters for the interim reports.      The 522 Order …

Bond Pharmacy, Inc. dba Advanced Infusion Solutions - 497408 - 03/23/2017

… Inc. d/b/a Advanced Infusion Solutions' Response to Warning Letter --Ref#: 2017-NOL-06 Dear Mr. Rivero: We … Administration ("FDA") this letter in response to FDA's Warning Letter dated March 1, 2017 (the "Warning Letter") to … according to FDA's published policy on warning letters, "the agency position is that Warning Letters are …

NuCare Pharmaceuticals Inc - 588096 - 09/26/2019

… WARNING LETTER         September 26, 2019       WL #1280     … the listing deficiencies detailed in multiple deficiency letters addressed to your company dated August 10, 2017, … 2017, and May 14, 2018. Forty-five days after these FDA letters were sent, emails of data removal notifications were …

Professional Compounding Centers of America dba PCCA - 597638 - 01/27/2021

… Warning Letter 320-21-15 January 27, 2021 AMENDED (This letter replaces Warning Letter No. 320-21-15 dated January 7, 2021) Dear Mr. … their drugs on import alert and/or issuing them warning letters. Drugs from multiple API suppliers used by PCCA were …

Draegar Medical Systems, Inc. - 596529 - 01/17/2020

… WARNING LETTER CMS # 596529 January 17, 2020 Dear Mr. Dräger: … whether the product may be legally marketed. Specifically, Letters to File dated May 1, 2013, January 15, 2014, April … us to assess your corrective actions. In response to this Warning Letter, you should provide confirmation that these …

Kang Zhang, M.D., Ph.D. - 511374 - 01/05/2017

…     10903 New Hapshire Avenue Silver Spring, MD  20993    WARNING LETTER     CERTIFIED MAIL RETURN RECEIPT REQUESTED   … E214 La Jolla, CA  92093-0946   Dear Dr. Zhang:   This Warning Letter informs you of objectionable conditions … protocol required subjects to have lost more than five letters from baseline best vision to be eligible for …

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 …

Hieber's Pharmacy - 542220 - 05/01/2020

… of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our … addressed the violations contained in these warning letters. You are expected to take all necessary steps to …

Hieber's Pharmacy - 480933 - 05/01/2020

… of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our … addressed the violations contained in these warning letters. You are expected to take all necessary steps to …

Avanthi, Inc. - 09/28/2018

… Promotion (OPDP) in response to OPDP’s December 19, 2017, Warning Letter concerning a violative exhibit panel (panel) … May 22, 2018 correspondences to OPDP in response to the Warning Letter and to OPDP’s January 26, 2018, and May 30, 2018 letters. OPDP’s Warning Letter requested that Avanthi …

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 …

VapeCentric, Inc. - 607375 - 11/20/2020

… of the U.S. Food and Drug Administration (FDA) issued a Warning Letter informing you that your e-liquid product (e.g. … May 18, 2020 and September 27, 2020, FDA received response letters from Phil Daman, Esq. at Daman & Associates, LLP on … were taken to address the violation identified in the Warning Letter and related concerns. Based upon our …

Pharmalab Enterprises, Inc. - 588432 - 12/10/2019

… December 10, 2019 Case # 588432 Warning Letter   Mr. Perez: The U.S. Food and Drug … Ave., Hialeah, Florida, from May 29 to June 17, 2019. This warning letter summarizes significant violations of current … common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used …