FDA Inspection
Cambridge Sensors Usa, LlcCambridge Sensors Usa, Llc – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns Cambridge Sensors Usa, Llc, with an inspection on November 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f92f4cb9-3113-4210-9ac3-fd58f48383a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070670
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 806.20(b)(5)Records of communications
- 21 CFR 806.20(b)(3)Events
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(b)Review and evaluation for investigation
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