FDA 483 Database
FDA Form 483s Issued in August 2021
Every published Form FDA 483 issued in August 2021, drawn from the FDA OII FOIA Electronic Reading Room. Each row links to the FDA source record.
16
Published 483s in August 2021
OII FOIA
Source
Form 483s issued in August 2021
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Samsung Biologics | 3010479596 | Active Pharmaceutical Ingredient Manufacturer | Republic of Korea | Aug 24, 2021 | FDA |
| Hugel Inc. | 3012163998 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | South Korea | Aug 20, 2021 | FDA |
| HomeChoice Partners dba BioScrip Infusion Services | 3014461693 | Producer of Sterile Drug Products | Georgia, United States | Aug 9, 2021 | FDA |
| New Vitalis Pharmacy LLC dba New Vitalis Pharmacy | 3014391500 | Producer of Sterile and Non Sterile Drug Products | Kentucky, United States | Aug 27, 2021 | FDA |
| Ranier's RX Laboratory | 3012124170 | Drug Manufacturer | Pennsylvania, United States | Aug 16, 2021 | FDA |
| Medoz Pharmacy of Polk Inc | 3015316526 | Producer of Non Sterile Drug Products | Florida, United States | Aug 27, 2021 | FDA |
| Intratheca l Compounding Specialists, LLC | 3006372310 | Producer of Sterile Drug Products | Louisiana, United States | Aug 19, 2021 | FDA |
| Eagle Pharmacy, Inc. | 3011688532 | Outsourcing Facility | Alabama, United States | Aug 12, 2021 | FDA |
| Chastains Inc. dba Owl Tri State Pharmacy | 1000107122 | Producer of Non Sterile Drug Products | Washington, United States | Aug 27, 2021 | FDA |
| Optum Compounding Services, LLC | 3012890460 | Outsourcing Facility | Arizona, United States | Aug 13, 2021 | FDA |
| First Royal Care Co. LLC, dba Red Mountain Compounding | 3015235235 | Producer of Sterile and Non Sterile Drug Products | Arizona, United States | Aug 11, 2021 | FDA |
| Revive Rx, LLC dba Revive Rx Pharmacy | 3016710945 | Producer of Sterile and Non Sterile Drug Products | Texas, United States | Aug 6, 2021 | FDA |
| IntegraDose Compounding Services LLC | 3014483112 | Outsourcing Facility | Minnesota, United States | Aug 2, 2021 | FDA |
| People's Custom Rx and Clinical Care, LLC | 3003780900 | Producer of Sterile Drug Products | Tennessee, United States | Aug 5, 2021 | FDA |
| Prescription Labs Inc dba Greenpark | 3009712882 | Producer of Sterile and Non Sterile Drug Products | Texas, United States | Aug 12, 2021 | FDA |
| Aurobindo Pharma Limited Unit 1 | 3004021253 | Active Pharmaceutical Ingredient Manufacturer | India | Aug 12, 2021 | FDA |