Ideal Implant Incorporated - 606103 - 05/14/2020

… WARNING LETTER CMS 606103   May 14, 2020 Dear Dr. Hamas: The … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Cadila Healthcare Limited - 584856 - 10/29/2019

… Warning Letter 320-20-05   October 29, 2019             Dear … Ahmedabad, from April 22 to May 3, 2019. This warning letter summarizes significant violations of current … . Repeat Violations at Facility In previous warning letters (WL 320-11-015 and 320-16-05), FDA cited similar CGMP …

Merete Medical GmbH - 571091 - 12/31/2018

… December 31, 2018 WARNING LETTER Dear Alexia Anapliotis: During an inspection … provided in response to the violations cited in this Warning Letter. We address your firm’s September 20, 2018 and … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Greiner Bio-One North America, Inc. - 606266 - 04/16/2020

… WARNING LETTER CMS # 606266 April 16, 2020 Dear Mr. … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Heavenly Natural Products - 607470 - 12/02/2020

… on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Vidco, Inc. - 516295 - 05/05/2017

… OVERNIGHT DELIVERY SIGNATURE REQUIRED   In reply refer to Warning Letter SEA 17-13   Charles B. Gibson, Jr., President … Vidco, Inc. 6175 SW 112 th Ave Beaverton, Oregon 97008   WARNING LETTER   Dear Mr. Gibson:   During an inspection of … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Suntraco Food Industries SDN BHD - 545371 - 02/08/2018

… 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 …

BHP Holdings Inc. dba BioPure Healing Products - 597687 - 06/17/2020

… June 17, 2020 In reply, refer to: CMS 597687 AMENDED WARNING LETTER Dear Ms. Floyd: The U.S. Food and Drug … issued to you on November 8, 2019. The response letters discussed corrective actions that your firm has …

Polymer Technology Systems, Inc. - 576934 - 07/31/2019

… WARNING LETTER CMS # 576934 July 31, 2019 Robert S. Huffstodt … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Viraldine, LLC - 625675 - 03/07/2022

… WARNING LETTER Date: March 7, 2022 RE: Unapproved New Drug … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Iotech International, LLC - 617715 - 03/15/2022

… WARNING LETTER DATE: March 15, 2022 Unapproved New Drug and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Empowered Diagnostics LLC - 638164 - 10/06/2022

… WARNING LETTER CMS# 638164 October 6, 2022 Dear Mr. … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

DeVilbiss Healthcare LLC - 619182 - 11/23/2021

…  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information … comprehensive and address all violations included in this Warning Letter.  If you have questions regarding any issues …

Kaltec Food Packaging Inc. - 553493 - 06/08/2018

… of Human and Animal Food Operations East Division 1    WARNING LETTER CMS# 553493   UNITED PARCEL SERVICE SIGNATURE … include critical factors which differ from the process letters provided by a process authority. No revised …

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 …

Cosmax NBT USA - 615933 - 05/03/2023

… May 03, 2023 WARNING LETTER Re: 615933 Dear Suk H. Cho: This is to advise … at http://www.fda.gov. We received your written response letters dated May 25, 2021, August 23, 2021, November 22, …

Pop Daddy Popcorn, LLC - 646807 - 03/28/2023

… WARNING LETTER FY23-HAFE6-03 CMS 646807 03/28/2023 Dear Mr. … materials received have the proper supplier docs: COAs, letters of guarantee, copies of third-party audits and/or …

Health & Wellness Center International One, L.L.C. dba Hotze Vitamins - 607276 - 12/02/2020

… on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Amnio Technology, LLC - 646460 - 10/01/2024

… WARNING LETTER October 1, 2024 CBER 24-646460 Dear Dr. … complaint procedure. We acknowledge receipt of your letters dated September 16, 2022, June 7, 2023, and December …

Euro Diagnostica AB - 524316 - 09/20/2017

…     10903 New Hampshire Avenue Silver Spring, MD 20993    WARNING LETTER SEPT 20, 2017 VIA UNITED PARCEL SERVICE   Ms. … provided in response to the violations cited in this Warning Letter. We address the 02/07/2017 and 03/31/2017 … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

ELITech Group B.V. - 534429 - 09/20/2017

…     10903 New Hampshire Avenue Silver Spring, MD 20993     WARNING LETTER SEP 20, 2017 VIA UNITED PARCEL SERVICE   … U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

BGP, LLC - 613144 - 05/19/2021

… WARNING LETTER Date: May 19, 2021 TO: adl@biocence.com … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

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 …

Sol-Millennium Medical, Inc. - 677524 - 03/18/2024

… WARNING LETTER CMS # 677524 March 18, 2024 Dear Mr. Lin: … any additional responses will be reviewed as part of your warning letter response. Unapproved Device Violations Our … Complaint Investigation Forms and Official Response Letters. The UDI is also not recorded on the Event Reporting …

Light Age, Inc. - 544047 - 01/24/2018

… 1 Montvale Ave Stoneham, MA 02180        January 24, 2018 WARNING LETTER CMS #544047 VIA UNITED PARCEL SERVICE Dr. … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …