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GOJO Industries Inc - 599132 - 11/30/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-11302020 … Dear Ms. Jaros: … the corrective actions your firm made in response to our Warning Letter #599132 issued January 17, 2020. We …
Creative Science, Inc. - 554119 - 10/08/2019
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/creative-science-inc-554119-10082019 … Dear Mr. … and September 6, 2019, email communications in response to Warning Letter Case# 554119. Your letters and email …
HNC Products Inc. - 607359 - 02/02/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/hnc-products-inc-607359-02022023 … Dear Dr. Potini: … 23, 2021; and February 16, 2022, letters in response to Warning Letter #607359. Your letters have been made a part of …
Med Shop Total Care Inc. - 628182 - 10/11/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/med-shop-total-care-inc-628182-10112023 … Dear Ms. … of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case …
Med Shop Total Care, Inc. - 581309 - 10/11/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/med-shop-total-care-inc-581309-10112023 … Dear Ms. … of your firm’s corrective actions in response to our warning letters (Case #581309) dated July 30, 2019, and (Case …
Auro Pharmacies, Inc. - 608369 - 04/11/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/auro-pharmacies-inc-608369-04112023 … Dear Dr. Patel: … of your firm’s corrective actions in response to our warning letters (WL 8-17 dated December 13, 2016, and WL CMS …
Chicago Indoor Garden - 606992 - 12/29/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/chicago-indoor-garden-606992-12292022 … Dear Mr. … of your firm’s corrective actions in response to our Warning Letters FY2020-HAFE-WL-04 and CHI-4-16. Based on our …
Dexcowin Co. Ltd. - 545388 - 10/25/2023
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/dexcowin-co-ltd-545388-10252023 … Dear Mr. Ryu: The … of your firm’s corrective actions in response to our Warning Letters (CMS Case No. 545388, dated February 20, …
Formulife, Inc. - 508605 - 03/02/2018
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/formulife-inc-508605-03022018 … Office of … of your firm's corrective actions in response to our Warning Letters (2012-DAL-WL-12, January 18, 2012; …
RightEye, LLC - 643192 - 12/20/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/righteye-llc-643192-12202022 … WARNING LETTER CMS# 643192 December 20, 2022 Dear Mr. Gross: …
Olympus Medical Systems Corporation - 546986 - 03/09/2018
… -compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-546986-03092018 … … 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER VIA UNITED PARCEL SERVICE March 9, … firm separately in advisories included in the decision letters for the interim reports. The 522 Order recommends …
Fujifilm - 546987 - 03/09/2018
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/fujifilm-546987-03092018 … 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER VIA UNITED PARCEL SERVICE March 9, …
Hoya Corporation - 546991 - Pentax Life Division
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/hoya-corporation-546991-pentax-life-division … … 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER VIA UNITED PARCEL SERVICE March 9, …
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
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/nucare-pharmaceuticals-inc-588096-09262019 … WARNING LETTER September 26, 2019 WL #1280 …
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
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/draegar-medical-systems-inc-596529-01172020 … WARNING LETTER CMS # 596529 January 17, 2020 Dear Mr. Dräger: …
Kang Zhang, M.D., Ph.D. - 511374 - 01/05/2017
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/kang-zhang-md-phd-511374-01052017 … 10903 New Hapshire Avenue Silver Spring, MD 20993 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED …
Muscle Sports Products, LLC - 625731 - 09/23/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/muscle-sports-products-llc-625731-09232022 … WARNING LETTER CMS # 625731 Dear Mr. Mancuso: This is to …
Hieber's Pharmacy - 480933 - 05/01/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/hiebers-pharmacy-480933-05012020 … Dear Ms. Mihalko: … of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our …
Hieber's Pharmacy - 542220 - 05/01/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/hiebers-pharmacy-542220-05012020 … Dear Ms. Mihalko: … of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our …
Avanthi, Inc. - 09/28/2018
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/avanthi-inc-09282018 … RE: ANDA 203495 LOMAIRA™ … Promotion (OPDP) in response to OPDP’s December 19, 2017, Warning Letter concerning a violative exhibit panel (panel) …
E Vapor Hut LLC - 626435 - 07/01/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/e-vapor-hut-llc-626435-07012022 … Dear April Hardy: … in your letters dated February 7, 2022, in response to our Warning Letter dated February 4, 2022. Based on our …
VapeCentric, Inc. - 607375 - 11/20/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/vapecentric-inc-607375-11202020 … Dear Michael … of the U.S. Food and Drug Administration (FDA) issued a Warning Letter informing you that your e-liquid product (e.g. …
Pharmalab Enterprises, Inc. - 588432 - 12/10/2019
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/pharmalab-enterprises-inc-588432-12102019 … December 10, 2019 Case # 588432 Warning Letter Mr. Perez: The U.S. Food and Drug …