Company
SpainGP Pharm SA, Sant Quinti De Mediona, Spain – FDA Inspections
Inspection records and compliance data for GP Pharm SA in Sant Quinti De Mediona. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 21, 2023.
Company Profile
This profile covers GP Pharm SA based in Sant Quinti De Mediona, Spain.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 4
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 27, 2015. Last inspected September 21, 2023.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
- Authority lacking to review records, investigate errors1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1305252 |
| October 2, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1149441 |
| May 21, 2019 | OAI | Human Drugs · Generic Drug Evaluation | 1091594 |
| June 20, 2018 | Not classified | Human Drugs | 1062872 |
| January 24, 2017 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1004446 |
| January 27, 2015 | VAI | Human Drugs · Drug Quality Assurance | 917365 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GP Pharm SA
FEI Number
3008345811
Address
Poligono Industrial Els Vinyets-Fogars, Sector 2, Carretera Comarcal 244 Km. 22, Sant Quinti De Mediona, Spain
Country
Spain
ID: dc9c0e23-15fc-4984-99e1-68b6e5ad0899