FDA Inspection
Philips IntelliSpace Event ManagementPhilips IntelliSpace Event Management – FDA Inspection, Jul 18, 2013
Record Details
This FDA Inspection record concerns Philips IntelliSpace Event Management, with an inspection on July 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 18, 2013
- Product Type
- Devices
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ID · 6a1458ed-cc82-4c59-afc6-df6cca1b33e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841413
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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