FDA Inspection
Bruker DaltronicsBruker Daltronics – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns Bruker Daltronics, with an inspection on October 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8dd15473-cc58-402a-8831-2169a76cb79e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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