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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 …
GPC Medical Ltd. - 536145 - 10/20/2017
… 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER VIA UNITED PARCEL SERVICE October 20, 2017 … U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
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 …
Zen Enterprises LLC - 678407 - 04/18/2024
… WARNING LETTER April 18, 2024 RE: WL 2644 Dear Mr. Makima: … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues … from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person …
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 …
Vivera Pharmaceuticals, Inc. - 614412 - 07/26/2021
… WARNING LETTER Date: July 26, 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 …
Vivera Pharmaceuticals, Inc. - 614382 - 07/26/2021
… WARNING LETTER Date: July 26, 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 …
Fusion Health and Vitality LLC - 607545 - 05/11/2020
… WARNING LETTER Date: May 11, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Alternative Health Experts LLC DBA Immunization Alternatives - 605884 - 04/06/2020
… WARNING LETTER Date: April 6, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
NRP Organics Ltd - 606066 - 04/08/2020
… WARNING LETTER Date: April 8, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Silfradent Srl - 592502 - 10/28/2019
… WARNING LETTER October 28, 2019 Dear Mr. Batani: During an … U.S. federal 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 …
Ehy Holdings, LLC - 675591 - 02/02/2024
… WARNING LETTER February 2, 2024 RE: WL #2642 Dear Jabez Liu: … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues … from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person …
Lexion Medical LLC - 613588 - 07/26/2021
… on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …
TEI Biosciences, Inc. - 573474 - 03/06/2019
… reviewed your firm’s response to FDA 483 observations 1-3 (Warning Letter cite 1 and 2 above) and conclude they are not … of your manufacturing processes. In response to this Warning Letter, you should confirm that your firm has … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Centro Mas Salud Dr. Gualberto Rabell-Fernandez - 537596 - 12/21/2017
… # 200 Maitland, FL 32751 Telephone: (407) 475-4700 WARNING LETTER CMS#537596 … be provided to the referring physicians and lay summary letters to the patients within 30 days of the date of the … or for delivery to the referring physician. Lay summary letters may be directly given to a patient at the time of the …
Dynavision International LLC - 525321 - 09/05/2017
… Ave. Stoneham, MA 02180 September 5, 2017 WARNING LETTER CMS # 525321 VIA UNITED PARCEL SERVICE Mr. … federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information …
Oxford Performance Materials, Inc. - 523250 - 05/01/2017
… 4th floor Stoneham, MA 02180 Phone (781) 587-7500 WARNING LETTER CMS # 523250 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
International Medsurg Connection, Inc. - 511426 - 05/08/2017
… (312) 353-5863 Fax: (312) 596-4187 May 8, 2017 WARNING LETTER CHI-9-17 UPS NEXT DAY SIGNATURE REQUIRED … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Amplicon Land, LLC - 607975 - 06/07/2021
… WARNING LETTER Date: June 7, 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 …
CreativeStar Solutions - 613535 - 03/04/2021
… WARNING LETTER Date: March , 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 …
Biopolygen Corp. - 613137 - 07/09/2021
… WARNING LETTER Date: July 9, 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 …
Trask and Roth Inc. dba Trask & Roth Research and Manufacturing - 609565 - 10/29/2020
… WARNING LETTER Date: October 29, 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 …
Industry Lab Diagnostic Partners - 609602 - 11/23/2020
… WARNING LETTER Date: November 20, 2020 RE: Adulterated … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …