Company
GermanySolupharm Pharmazeutische Erzeugnisse Gmbh, Melsungen, Germany – FDA Inspections
Inspection records and compliance data for Solupharm Pharmazeutische Erzeugnisse Gmbh in Melsungen. 5 FDA inspections on record, 1 Form 483, last inspected July 29, 2022.
Company Profile
This profile covers Solupharm Pharmazeutische Erzeugnisse Gmbh based in Melsungen, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 22, 2011. Last inspected July 29, 2022.
Most cited issue areas
- Clothing appropriate for duties performed1 inspection
- Complete Test Data1 inspection
- Deviations of production time limits1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1201236 |
| February 2, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1039841 |
| June 21, 2016 | VAI | Human Drugs · Drug Quality Assurance | 980047 |
| September 22, 2014 | VAI | Human Drugs · Drug Quality Assurance | 897666 |
| November 22, 2011 | NAI | Human Drugs · Drug Quality Assurance | 756529 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Solupharm Pharmazeutische Erzeugnisse Gmbh
FEI Number
3008255368
Address
Industriestr. 3, Melsungen, Germany
Country
Germany
ID: dd3d4b95-d76b-4afa-b430-f1dee1ebb184