Company
GermanyBODE Chemie GmbH, Hamburg, Germany – FDA Inspections
Inspection records and compliance data for BODE Chemie GmbH in Hamburg. 2 FDA inspections on record, 1 Form 483, last inspected September 29, 2017.
Company Profile
This profile covers BODE Chemie GmbH based in Hamburg, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 23, 2015. Last inspected September 29, 2017.
Most cited issue areas
- Cleaning SOPs/equipment protection1 inspection
- Component addition checked by 2nd person1 inspection
- Computer control of master formula records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 29, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1027015 |
| October 23, 2015 | VAI | Human Drugs · Drug Quality Assurance | 949088 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BODE Chemie GmbH
FEI Number
3004007328
Address
Melanchthonstr. 27, Hamburg, Germany
Country
Germany
ID: 6c934f69-3d12-403a-83cc-cf148b98d797