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
16
Distinct firms
Form 483s issued in August 2021
Samsung BiologicsFDA
- FEI
- 3010479596
- Issued
- Aug 24, 2021
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- Republic of Korea
Hugel Inc.FDA
- FEI
- 3012163998
- Issued
- Aug 20, 2021
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- South Korea
HomeChoice Partners dba BioScrip Infusion ServicesFDA
- FEI
- 3014461693
- Issued
- Aug 9, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Georgia, United States
New Vitalis Pharmacy LLC dba New Vitalis PharmacyFDA
- FEI
- 3014391500
- Issued
- Aug 27, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Kentucky, United States
Ranier's RX LaboratoryFDA
- FEI
- 3012124170
- Issued
- Aug 16, 2021
- Establishment
- Drug Manufacturer
- Location
- Pennsylvania, United States
Medoz Pharmacy of Polk IncFDA
- FEI
- 3015316526
- Issued
- Aug 27, 2021
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Florida, United States
Intratheca l Compounding Specialists, LLCFDA
- FEI
- 3006372310
- Issued
- Aug 19, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Louisiana, United States
Eagle Pharmacy, Inc.FDA
- FEI
- 3011688532
- Issued
- Aug 12, 2021
- Establishment
- Outsourcing Facility
- Location
- Alabama, United States
Chastains Inc. dba Owl Tri State PharmacyFDA
- FEI
- 1000107122
- Issued
- Aug 27, 2021
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Washington, United States
Optum Compounding Services, LLCFDA
- FEI
- 3012890460
- Issued
- Aug 13, 2021
- Establishment
- Outsourcing Facility
- Location
- Arizona, United States
First Royal Care Co. LLC, dba Red Mountain CompoundingFDA
- FEI
- 3015235235
- Issued
- Aug 11, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Arizona, United States
Revive Rx, LLC dba Revive Rx PharmacyFDA
- FEI
- 3016710945
- Issued
- Aug 6, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Texas, United States
IntegraDose Compounding Services LLCFDA
- FEI
- 3014483112
- Issued
- Aug 2, 2021
- Establishment
- Outsourcing Facility
- Location
- Minnesota, United States
People's Custom Rx and Clinical Care, LLCFDA
- FEI
- 3003780900
- Issued
- Aug 5, 2021
- Establishment
- Producer of Sterile Drug Products
- Location
- Tennessee, United States
Prescription Labs Inc dba GreenparkFDA
- FEI
- 3009712882
- Issued
- Aug 12, 2021
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Texas, United States
Aurobindo Pharma Limited Unit 1FDA
- FEI
- 3004021253
- Issued
- Aug 12, 2021
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- India
| 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 |