Company
PortugalBial Portela & Ca. S.A., South Mamede Do Coronado, Portugal – FDA Inspections
Inspection records and compliance data for Bial Portela & Ca. S.A. in South Mamede Do Coronado, -. 6 FDA inspections on record, 1 Form 483, last inspected June 21, 2024.
Company Profile
This profile covers Bial Portela & Ca. S.A. based in South Mamede Do Coronado, Portugal.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 15, 2009. Last inspected June 21, 2024.
Most cited issue areas
- Establishment of calibration procedures1 inspection
- Reports of Analysis (Components)1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 21, 2024 | VAI | Human Drugs · New Drug Evaluation | 1242424 |
| May 6, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1278112 |
| May 10, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1115591 |
| November 12, 2015 | VAI | Human Drugs · Drug Quality Assurance | 950439 |
| December 12, 2012 | NAI | Human Drugs · Drug Quality Assurance | 810978 |
| September 15, 2009 | NAI | Human Drugs · Drug Quality Assurance | 616316 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
Bial Portela & Ca. S.A.
FEI Number
3007703969
Address
A Avenida Da Siderurgia Nacional, South Mamede Do Coronado, - -, Portugal
Country
Portugal
ID: 7837a385-d8bc-48b7-ab49-13423bbf1223