News Articles | RAPS - Regulatory Affairs Professionals Society
22 hours ago — “FDA has concerns about the use of certain drugs prepared by compounders to treat COVID-19,” wrote the agency on its web page addressing compounding
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
3/04/2021 | 03/04/2021 | Kogniz, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded | ||
03/04/2021 | 03/04/2021 | Omega Engineering Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Dubak Electrical Group | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Learn about the types of warning letters on FDA's website.
Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter |
---|---|---|---|---|---|---|
03/05/2021 | 03/04/2021 | CreativeStar Solutions | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Cantronic Systems Inc. | Center for Devices and Radiological Health | Device Adulterated and Misbranded | ||
03/04/2021 | 03/04/2021 | Certify Global Inc. | Center for Devices and Radiological Health | Device Adulterated and Misbranded | ||
03/04/2021 | 02/18/2021 | Mercola.com, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 02/18/2021 | B4B Corp. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 02/18/2021 | SafaLab, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Thermavis | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Opgal Optronic Industries Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Thermoteknix System Limited | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/04/2021 | 03/04/2021 | Omnisense Systems Pte Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
03/09/2021 | 08/24/2017 | Cipher Pharmaceuticals Inc. C/O Willcox & Savage, P.C. | Office of Prescription Drug Promotion | Labeling/False & Misleading Claims/Misbranded | ||
03/09/2021 | 11/14/2017 | Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. | Office of Prescription Drug Promotion | Labeling/False & Misleading Claims/Misbranded | ||
03/09/2021 | 03/01/2021 | Cannafyl | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
03/09/2021 | 03/01/2021 | Gaza Proveedora De Servicios De Hospedaje Y Alimentacion | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
03/09/2021 | 03/01/2021 | Plasticos Las Palmas, S.A. de C.V | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
03/09/2021 | 03/01/2021 | Marco Antonio Rodriguez Fierro | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
03/09/2021 | 03/02/2021 | Evelyn Lopez-Brignoni, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | ||
03/08/2021 | 03/05/2021 | CAMA Wellness Center/IodoRios Company, LLC | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/05/2021 | 03/04/2021 | Workswell Group s.r.o. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
03/05/2021 | 03/04/2021 | Westminster International Ltd | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |