Company
GermanyBruker Daltronics, Bremen, Germany – FDA Inspections
Inspection records and compliance data for Bruker Daltronics in Bremen. 1 FDA inspection on record, 1 Form 483, last inspected October 18, 2018.
Company Profile
This profile covers Bruker Daltronics based in Bremen, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected October 18, 2018.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 18, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1069501 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bruker Daltronics
FEI Number
3010191749
Address
Fahrenheitstr. 4, Bremen, Germany
Country
Germany
ID: 9b27f10b-e19e-45bf-88d8-7c133ab2a5d0