FDA 483 Database
FDA Form 483s Issued in 2019
Every published Form FDA 483 issued in 2019, drawn from the FDA OII FOIA Electronic Reading Room. Drill into any month, or open a record to see the firm, FEI number, establishment type, and location.
155
Published 483s in 2019
12
Months with records
Browse 2019 by month
Most recent Form 483s in 2019
Showing 25 of 155 — open a month above for the full list.
Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty PharmacyFDA
- FEI
- 3015133983
- Issued
- Apr 17, 2019
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Washington, United States
Compounded Solutions in PharmacyFDA
- FEI
- 3012039582
- Issued
- Aug 29, 2019
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Connecticut, United States
CMC Enterprise PharmacyFDA
- FEI
- 3014539004
- Issued
- Mar 22, 2019
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- North Carolina, United States
Triangle Compounding Pharmacy IncFDA
- FEI
- 3004969894
- Issued
- Apr 4, 2019
- Establishment
- Producer of Sterile Drug Products
- Location
- North Carolina, United States
Hubei Gedian Humanwell Pharmaceutical Co., Ltd.FDA
- FEI
- 3004117486
- Issued
- Jun 28, 2019
- Establishment
- Active Pharmaceutical Ingredient Manufacturer
- Location
- China
Takeda Pharmaceutical Company LimitedFDA
- FEI
- 3004664162
- Issued
- Nov 24, 2019
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Japan
Ranier’s Compounding LaboratoryFDA
- FEI
- 3012124170
- Issued
- Feb 6, 2019
- Establishment
- Producer of Sterile Drug Products
- Location
- Pennsylvania, United States
Recipharm MontsFDA
- FEI
- 1000171152
- Issued
- Nov 12, 2019
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- France
Abbott NutritionFDA
- FEI
- 1815692
- Issued
- Sep 24, 2019
- Establishment
- Medical Food Manufacturer (Pediatric OES)
- Location
- Michigan, United States
Bravo Packing, Inc.FDA
- FEI
- 1000121624
- Issued
- Aug 6, 2019
- Establishment
- Manufacturer
- Location
- New Jersey, United States
Wuxi BiologicsFDA
- FEI
- 3010606982
- Issued
- Apr 16, 2019
- Establishment
- Active Pharmaceutical Ingredient & Finished Dosage Manufacturer
- Location
- China
Emergent BioSolutions Canada Inc.FDA
- FEI
- 3003153579
- Issued
- Sep 13, 2019
- Establishment
- Finished Pharmaceutical Manufacturer
- Location
- Canada
BAYCARE INTEGRATED SERVICE CENTERFDA
- FEI
- 3013023419
- Issued
- Dec 10, 2019
- Establishment
- Outsourcing Facility
- Location
- Florida, United States
Life Science Pharmacy IncFDA
- FEI
- 3006997792
- Issued
- Nov 20, 2019
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- New York, United States
3015212514FDA
- FEI
- Unknown
- Issued
- Apr 26, 2019
- Establishment
- Sponsor
- Location
- Minnesota, United States
3015213291FDA
- FEI
- Unknown
- Issued
- Apr 23, 2019
- Establishment
- Sponsor
- Location
- Minnesota, United States
Surgery Pharmacy Services, Inc.FDA
- FEI
- 3010704905
- Issued
- Dec 6, 2019
- Establishment
- Producer of Sterile Drug Products
- Location
- Tennessee, United States
Infusion Systems of SW Florida Inc. dba Myerlee PharmacyFDA
- FEI
- 3011123993
- Issued
- Dec 17, 2019
- Establishment
- Producer of Sterile and Non Sterile Drug Products
- Location
- Florida, United States
ImClone Systems, L.L .C.FDA
- FEI
- 3002889358
- Issued
- Nov 26, 2019
- Establishment
- Biological Drug Manufacturer
- Location
- New Jersey, United States
RC Outsourcing LLCFDA
- FEI
- 3011967886
- Issued
- Feb 8, 2019
- Establishment
- Outsourcing Facility
- Location
- Ohio, United States
Farmakeio Outsourcing LLCFDA
- FEI
- 3014982757
- Issued
- Oct 30, 2019
- Establishment
- Outsourcing Facility
- Location
- Texas, United States
RC Outsourcing LLCFDA
- FEI
- 3011967886
- Issued
- Feb 8, 2019
- Establishment
- Outsourcing Facility
- Location
- Ohio, United States
One Way Drug dba Partell Specialty PharmacyFDA
- FEI
- 3011769075
- Issued
- Nov 25, 2019
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Nevada, United States
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding CenterFDA
- FEI
- 3011158388
- Issued
- Nov 15, 2019
- Establishment
- Outsourcing Facility
- Location
- South Carolina, United States
Keystone Rx LLCFDA
- FEI
- 3015119302
- Issued
- Jul 12, 2019
- Establishment
- Producer of Non Sterile Drug Products
- Location
- Pennsylvania, United States
| Company | FEI | Establishment type | Location | Issued | Source |
|---|---|---|---|---|---|
| Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy | 3015133983 | Producer of Sterile and Non Sterile Drug Products | Washington, United States | Apr 17, 2019 | FDA |
| Compounded Solutions in Pharmacy | 3012039582 | Producer of Sterile and Non Sterile Drug Products | Connecticut, United States | Aug 29, 2019 | FDA |
| CMC Enterprise Pharmacy | 3014539004 | Producer of Sterile and Non Sterile Drug Products | North Carolina, United States | Mar 22, 2019 | FDA |
| Triangle Compounding Pharmacy Inc | 3004969894 | Producer of Sterile Drug Products | North Carolina, United States | Apr 4, 2019 | FDA |
| Hubei Gedian Humanwell Pharmaceutical Co., Ltd. | 3004117486 | Active Pharmaceutical Ingredient Manufacturer | China | Jun 28, 2019 | FDA |
| Takeda Pharmaceutical Company Limited | 3004664162 | Finished Pharmaceutical Manufacturer | Japan | Nov 24, 2019 | FDA |
| Ranier’s Compounding Laboratory | 3012124170 | Producer of Sterile Drug Products | Pennsylvania, United States | Feb 6, 2019 | FDA |
| Recipharm Monts | 1000171152 | Finished Pharmaceutical Manufacturer | France | Nov 12, 2019 | FDA |
| Abbott Nutrition | 1815692 | Medical Food Manufacturer (Pediatric OES) | Michigan, United States | Sep 24, 2019 | FDA |
| Bravo Packing, Inc. | 1000121624 | Manufacturer | New Jersey, United States | Aug 6, 2019 | FDA |
| Wuxi Biologics | 3010606982 | Active Pharmaceutical Ingredient & Finished Dosage Manufacturer | China | Apr 16, 2019 | FDA |
| Emergent BioSolutions Canada Inc. | 3003153579 | Finished Pharmaceutical Manufacturer | Canada | Sep 13, 2019 | FDA |
| BAYCARE INTEGRATED SERVICE CENTER | 3013023419 | Outsourcing Facility | Florida, United States | Dec 10, 2019 | FDA |
| Life Science Pharmacy Inc | 3006997792 | Producer of Sterile and Non Sterile Drug Products | New York, United States | Nov 20, 2019 | FDA |
| 3015212514 | Unknown | Sponsor | Minnesota, United States | Apr 26, 2019 | FDA |
| 3015213291 | Unknown | Sponsor | Minnesota, United States | Apr 23, 2019 | FDA |
| Surgery Pharmacy Services, Inc. | 3010704905 | Producer of Sterile Drug Products | Tennessee, United States | Dec 6, 2019 | FDA |
| Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy | 3011123993 | Producer of Sterile and Non Sterile Drug Products | Florida, United States | Dec 17, 2019 | FDA |
| ImClone Systems, L.L .C. | 3002889358 | Biological Drug Manufacturer | New Jersey, United States | Nov 26, 2019 | FDA |
| RC Outsourcing LLC | 3011967886 | Outsourcing Facility | Ohio, United States | Feb 8, 2019 | FDA |
| Farmakeio Outsourcing LLC | 3014982757 | Outsourcing Facility | Texas, United States | Oct 30, 2019 | FDA |
| RC Outsourcing LLC | 3011967886 | Outsourcing Facility | Ohio, United States | Feb 8, 2019 | FDA |
| One Way Drug dba Partell Specialty Pharmacy | 3011769075 | Producer of Non Sterile Drug Products | Nevada, United States | Nov 25, 2019 | FDA |
| Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center | 3011158388 | Outsourcing Facility | South Carolina, United States | Nov 15, 2019 | FDA |
| Keystone Rx LLC | 3015119302 | Producer of Non Sterile Drug Products | Pennsylvania, United States | Jul 12, 2019 | FDA |