Company
GermanyEurofins Dr. Specht International GmbH, Hamburg, Germany – FDA Inspections
Inspection records and compliance data for Eurofins Dr. Specht International GmbH in Hamburg. 2 FDA inspections on record, 1 Form 483, last inspected February 02, 2018.
Company Profile
This profile covers Eurofins Dr. Specht International GmbH based in Hamburg, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 10, 2013. Last inspected February 2, 2018.
Most cited issue areas
- Computer control of master formula records1 inspection
- Identification of Person Performing Review of Lab Records1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1039985 |
| July 10, 2013 | NAI | Human Drugs · Drug Quality Assurance | 841943 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Eurofins Dr. Specht International GmbH
FEI Number
3005774220
Address
Am Neulander Gewerbepark 2, Hamburg, Germany
Country
Germany
ID: 2eb18149-9fdf-4790-881b-911d9d5c3090