FDA Inspection
Vital Signs Devices, a GE Healthcare CompanyVital Signs Devices, a GE Healthcare Company – FDA Inspection, Apr 15, 2011
Record Details
This FDA Inspection record concerns Vital Signs Devices, a GE Healthcare Company, with an inspection on April 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 15, 2011
- Product Type
- Devices
View Company Profile
ID · d36f3e97-6420-457a-8ffd-7bfacd3767dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717997
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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