FDA Inspection
Bruker Daltonics, Inc.Bruker Daltonics, Inc. – FDA Inspection, Apr 1, 2016
Record Details
This FDA Inspection record concerns Bruker Daltonics, Inc., with an inspection on April 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bruker Daltonics, Inc.
- Inspection Date
- April 1, 2016
- Product Type
- Devices
View Company Profile
ID · 4aeaaab8-df4e-42db-b1cb-80c2f39fda23
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964861
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
3- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bruker Daltonics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bruker Daltonics, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.