Company
United StatesBruker Daltonics, Inc., Billerica, MA – FDA Inspections
Inspection records and compliance data for Bruker Daltonics, Inc. in Billerica, Massachusetts. 2 FDA inspections on record, last inspected May 18, 2018.
Company Profile
This profile covers Bruker Daltonics, Inc. based in Billerica, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 1, 2016. Last inspected May 18, 2018.
Most cited issue areas
- Design output - documentation1 inspection
- Failure to submit, distinct marking1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1054427 |
| April 1, 2016 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 964861 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bruker Daltonics, Inc.
FEI Number
3003961381
Address
40 Manning Rd, Billerica, Massachusetts 01821, United States
Country
United States
ID: 7ea3f57a-bd56-43c8-89d4-3e71d7f7bb59