Vikshara Trading & Investments Ltd. - 516856 - 04/28/2017

… Warning Letter 320-17-37   April 28, 2017     Mr. Tushar … operator has delayed and/or limited an inspection.   This warning letter summarizes significant violations of current … of the strike, including copies of employee resignation letters and a photograph of striking employees blocking the …

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 …

Criticare Technologies Inc - 523101 - 04/21/2017

… Avenue, 4th floor Stoneham, MA 02180 Phone 781.587.7500    WARNING LETTER CMS # 523101 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Rapid Release Technologies - 507144 - 01/17/2017

… District 19701 Fairchild Road Los Angeles, CA 92612    WARNING LETTER   UNITED PARCEL SERVICE SIGNATURE REQUIRED   … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …

SynCardia Systems LLC - 537226 - 04/03/2018

… Division 3 West 19701 Fairchild Irvine, CA 92612    WARNING LETTER CMS #537226   UNITED PARCEL SERVICE SIGNATURE … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …

Pelvic Therapies, Inc - 518409 - 10/17/2017

… 3 West 19701 Fairchild Road Irvine, CA 92612        WARNING LETTER VIA HAND DELIVERY October 17, 2017 WL# … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

Vivify Holistic Clinic - 604883 - 03/06/2020

… WARNING LETTER Date: March 6, 2020 TO: … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

The Golden Road Kratom - 607627 - 05/15/2020

… WARNING LETTER Date:               May 15, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Media Networks Sydney Pty Limited - 687044 - 08/15/2024

… WARNING LETTER Date: August 15, 2024 RE: WL# 2716 Dear Gilad … 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 …

Aegle Nutrition LLC - 546966 - 07/06/2018

… Texas 75204    July 6, 2018   Ref# CMS Case 546966   WARNING LETTER   UPS Overnight   John Ramsey, President Aegle … Lot Number Tr92711701 Furthermore, your process authority letters for these three products are incomplete in that the … letter does not list any heat treatments on these three letters.    We have reviewed your response, dated December …

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 …

BioModeling Solutions, Inc. - 540821 - 01/12/2018

… Division 3 West 19701 Fairchild Irvine, CA 92612        WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED … Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information …

Amcyte Pharma, Inc. - 623474 - 01/03/2022

… WARNING LETTER Date: January 3, 2022 RE: Unapproved and … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Secret of the Islands - 616344 - 08/10/2021

… WARNING LETTER Date:  August 10, 2021 TO:    … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Earth Angel Oils - 605752 - 04/14/2020

… WARNING LETTER Date:               April 14, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Ionogen, LLC - 608909 - 07/07/2020

… WARNING LETTER   Date:               July 7, 2020 … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …

Walgreen Company - 662158 - 09/12/2023

… WARNING LETTER September 12, 2023 RE: WL 2512 Dear Elena … 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 …

Dollar Tree, Inc. - 629509 - 11/08/2022

… Additional Considerations Your corporation received a Warning Letter (320-20-07 1 sent to Greenbrier International … the Act, [21 U.S.C. § 331(c)]. Of particular concern, the Warning Letter detailed FDA evidence that Dollar Tree, parent … -compliance-enforcement-and-criminal-investigations/warning-letters/bicooya-cosmetics-limited-533477-08112017 … Center …

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 …

Hebei Pukang Medical Instruments Co., Ltd. - 518493 - 03/29/2017

…     10903 New Hampshire Avenue Silver Spring, MD 20993    WARNING LETTER VIA UNITED PARCEL SERVICE MAR 29, 2017   … your firm should provide a written response to this Warning Letter as described below and correct the violations … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …

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 …

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 …