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Pharmalab Enterprises, Inc. - 588432 - 12/10/2019
… December 10, 2019 Case # 588432 Warning Letter Mr. Perez: The U.S. Food and Drug … Ave., Hialeah, Florida, from May 29 to June 17, 2019. This warning letter summarizes significant violations of current … common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used …
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 …
Lymol Medical Corp - 570153 - 01/08/2019
… WARNING LETTER Jan 8, 2019 VIA UNITED PARCEL SERVICE … money penalties. Other federal agencies may take this Warning Letter into account when considering the award of … to your NDA with the following wording in bold, capital letters at the top of the first page, as follows: PMR/PMC …
Opternative Inc - 532477 - 10/30/2017
… 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER October 30, 2017 Aaron Dallek, CEO … Also, 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 …
Boehringer Ingelheim Animal Health USA - 674535 - 03/01/2024
… Senvelgo (velagliflozin oral solution) CMS #: 674535 WARNING LETTER Dear Mr. Legg: The U.S. Food and Drug … misleading promotional communication contradicts the boxed warning, contraindications, and approved indication of your … insulin.” 2 Senvelgo’s FDA-approved PI contains a boxed warning due to increased risk of diabetic ketoacidosis (DKA) …
Health-Chem Diagnostics, LLC - 526232 - 12/07/2017
… 200 Maitland, FL 32751 Telephone: (407) 475-4700 WARNING LETTER CMS# 526232 UNITED PARCEL SERVICE w/DELIVERY … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this …
RPK Pharmaceuticals Inc. - 613400 - 03/26/2021
… WARNING LETTER March 26, 2021 WL # 1663 Dear Rich Mangini: … below. We note that FDA previously sent your firm two letters, one on April 13, 2020 notifying you of listing … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues …
RiteAid Corporation - 643207 - 10/19/2022
… Warning Letter October 19, 2022 RE: WL 2277 Dear Ms. Horton: … We note that FDA previously sent you and your firm two letters on this same subject, one on December 6, 2021, … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues …
ECI Pharmaceuticals, LLC - 625254 - 02/03/2022
… Warning Letter WL#2267 February 3, 2022 Dear John Copanos: … below. We note that FDA previously sent your firm two letters, one on October 26, 2021 notifying you of listing … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues …
ECI Pharmaceuticals, LLC - 625254 - 02/03/2022
… Warning Letter WL#2267 February 3, 2022 Dear John Copanos: … below. We note that FDA previously sent your firm two letters, one on October 26, 2021 notifying you of listing … reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues …
Medtronic Puerto Rico Operations Co. - 562437 - 08/23/2018
… Pl # 200 Maitland, FL 32751 Telephone: (407) 475-4700 WARNING LETTER CMS # 562437 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
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 …
Vertical Pharmaceuticals, Inc - 516774 - 05/10/2017
… 10 Waterview Blvd. 3rd Floor Parsippany, New Jersey 07054 WARNING LETTER May 10, 2017 VIA UNITED PARCEL SERVICE … New Jersey 08807 Dear Mr. Markinson: This Warning Letter informs you of objectionable … agencies are advised of the issuance of all Warning Letters about drugs and dev ices so that they may take this …
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 …
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - 560736 - 07/30/2018
… Pl # 200 Maitland, FL 32751 Telephone: (407) 47S-4700 WARNING LETTER CMS # 560736 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
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 …
Life Rising Corporation - 516209 - 05/25/2017
… (312) 353-5863 Fax: (312) 596-4187 May 25, 2017 WARNING LETTER CHI-10-17 UPS NEXT DAY SIGNATURE … by 21 CFR 111.75(c). We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. You … record (21 CFR 111.105). We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. You …
Unetixs Vascular Inc. - 523178 - 04/25/2017
… Avenue, 4th floor Stoneham, MA 02180 Phone 781.587.7500 WARNING LETTER CMS # 523178 … Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
The Ben Heggy Candy Company - 633394 - 09/23/2022
… September 23, 2022 Warning Letter 633394 Dear Mr. Wollenberg: The U.S. Food and … common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the …
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 …