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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 …
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 …
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 …
Kennedy, Philip R. - 597587 - 02/27/2020
… February 27, 2020 WARNING LETTER Dear Dr. Kennedy: This Warning Letter is to inform you of objectionable conditions … In your written response, you stated that there are letters from the IRB. However, the IRB correspondences …
Conformis Inc. - 596362 - 12/10/2019
… WARNING LETTER CMS # 596362 December 10, 2019 Dear Mr. … under routine operating conditions. In response to this Warning Letter, you should address how you plan to (1) … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Namsa - 544884 - 10/07/2022
… corrective and preventive actions in response to our Warning Letter (WL) dated March 23, 2018, and the follow up … the corrective actions, as promised in your response letters, dated October 11, 2021, December 31, 2021, April 3, …
American Preclinical Services - 562382 - 08/09/2021
… corrective and preventive actions in response to our Warning Letter (WL) dated February 12, 2019. Based on our … the corrective actions, as promised in your response letters, dated October 25, 2018, November 9, 2018, November …
Smiths Medical ASD Inc. - 617147 - 10/01/2021
… WARNING LETTER CMS # 617147 October 1, 2021 Dear Mr. Noor: … History File for the Medfusion® 4000, found at least 5 Letters to File have not been retained. We acknowledge your … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …
Physician 360, Inc. - 604202 - 10/05/2020
… WARNING LETTER October 5, 2020 Dear Dr. Lapporte: The Food … Also, f ederal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Induction Therapies, LLC - 616487 - 11/23/2021
… WARNING LETTER CMS # 616487 November 23, 2021 Dear Ms. … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Curewave Lasers LLC - 593692 - 12/12/2019
… WARNING LETTER CMS: 593692 December 12, 2019 Dear Mr. … Letter - Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …
Circulatory Technology, Inc. - 572970 - 01/28/2019
… WARNING LETTER CMS # 572970 UNITED PARCEL SERVICE OVERNIGHT … is not a substitute for revalidation. In response to this Warning Letter, you should provide evidence that the process … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
LC Medical Concepts, Inc - 571232 - 01/31/2019
… WARNING LETTER CMS # 571232 UNITED PARCEL SERVICE OVERNIGHT … manufactured in the former facility. In response to this Warning Letter, you should provide a summary of your … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Unetixs Vascular, Inc. - 598016 - 02/04/2020
… WARNING LETTER CMS # 598016 February 4, 2020 Dear Mr. Jha: … address these systemic deficiencies. In response to this Warning Letter, you should provide a summary of your CAPA … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
American Contract Systems - 568066 - 11/06/2018
… WARNING LETTER CMS # 568066 UNITED PARCEL SERVICE OVERNIGHT … 2019. This timeline is unacceptable. In response to this Warning Letter, you should provide your plans to ensure that … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Innova Medical Group, Inc. - 614819 - 06/10/2021
… WARNING LETTER CMS # 614819 June 10, 2021 Dear Mr. Elliot: … Also, federal agencies may be advised of the issuance of Warning Letters about devices and may take your compliance with Act …
Surgisil, LLP - 567886 - 04/15/2019
… UNITED PARCEL SERVICE OVERNIGHT DELIVERY WARNING LETTER CMS: 567886 April 15, 2019 Peter Raphael, MD, … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
M Dialysis AB - 554169 - 06/06/2018
… WARNING LETTER June 6, 2018 Dear Mr. Nord: During an … your firm should provide a written response to this Warning Letter as described below and correct the … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Mandelay Kft - 603799 - 02/03/2020
… February 3, 2020 WARNING LETTER Dear Mr. Kornél Tókics: During an inspection … your firm should provide a written response to this Warning Letter as described below and correct the … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Nikkiso Medical America, Inc - 613109 - 05/07/2021
… WARNING LETTER May 7, 2021 Refer to CPT1900751; CMS #613109 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Lusys Laboratories, Inc. - 625807 - 02/17/2022
… WARNING LETTER Date: February 17, 2022 TO: 7220 Trade St. … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Block Scientific - 609533 - 03/18/2021
… WARNING LETTER Date: March 18, 2021 RE: Adulterated and … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Silkprousa LLC - 608493 - 08/18/2020
… WARNING LETTER RE: CMS Case #608493 Dear Marilyn Dans: The … Also, f ederal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
EnMed MicroAnalytics, Inc. - 610131 - 01/25/2021
… WARNING LETTER Date: January 25, 2021 RE: Adulterated and … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Lepu Medical Technology -Beijing- Co., Ltd. - 614908 - 07/29/2021
… WARNING LETTER Date: July 29, 2021 RE: Adulterated and … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …