Company
PortugalBluepharma Industria Farmaceutica, S.A., Coimbra, Portugal – FDA Inspections
Inspection records and compliance data for Bluepharma Industria Farmaceutica, S.A. in Coimbra. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected May 13, 2022.
Company Profile
This profile covers Bluepharma Industria Farmaceutica, S.A. based in Coimbra, Portugal.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 8, 2009. Last inspected May 13, 2022.
Most cited issue areas
- Complete Test Data1 inspection
- Deviations from laboratory control requirements1 inspection
- Drug product reserve containers1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 13, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1226152 |
| May 24, 2019 | OAI | Human Drugs · Generic Drug Evaluation | 1090994 |
| October 28, 2016 | VAI | Human Drugs · Drug Quality Assurance | 993040 |
| July 24, 2014 | NAI | Human Drugs · Drug Quality Assurance | 893007 |
| July 26, 2012 | VAI | Human Drugs · Drug Quality Assurance | 801000 |
| October 8, 2009 | NAI | Human Drugs · Drug Quality Assurance | 624356 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bluepharma Industria Farmaceutica, S.A.
FEI Number
3007007549
Address
Rua Da Bayer, Coimbra, Portugal
Country
Portugal
ID: db45cabc-11ee-4fa5-af43-c13998bac44e