Regulatory Impact Analysis
6 days ago — ... Compounding Lists (DDC lists). Currently, we are not aware of any marketing of compounded drugs in the three proposed categories of human drug products.
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
Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA
ivsupplyclinic.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
Fresenius Kabi AG | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||
Innovative Formulations, LLC dba Insane Labz | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Thai Nakorn Patana Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
Barsotti Juice Company, Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||
Native Salts LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Gilster-Mary Lee Corporation | Division of Human and Animal Food Operations East VI | Food Labeling/Misbranded | |||
Bell International Laboratories, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||
Agila Corporation dba Woody’s Pet Food Deli | Division of Human and Animal Food Operations West I | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated | |||
Colgin, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
Dream Wholesale, Inc | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
Cosmetic Specialty Labs, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
Fresenius Kabi AG | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
Nobles Medical Technology II, Inc. | Center for Devices and Radiological Health | Investigational Review Board (IRB) | |||
Boehringer Ingelheim Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded | |||
Spirochaete Research Labs, LLC aka Scitus Laboratory Products | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||
Human Microbes | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
Dermal Source, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Indelicare DBA INKEEZE | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Tattoo Numbing Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Wagco Distribution, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
Jiangsu Shenli Medical Production Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
Sol-Millennium Medical, Inc. | Division of Medical Device and Radiological Health Operations Central | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||
Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
Furst-McNess Company | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated | |||
Skull Smash LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
ReNovo, Inc. DBA Provision Device Reprocessing Solutions | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||
Deqing Jiarou Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
Sky Bank Media, LLC dba Painless Tattoo Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Higley Industries, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||
Ammonia Sport Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
SeeNext Venture, Ltd. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Dermal Source, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |