FDA Inspection
Rocket Medical PLCRocket Medical PLC – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Rocket Medical PLC, with an inspection on July 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 90e3dde1-86ff-46ff-8da8-623cb1fb5c3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020044
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Rocket Medical PLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rocket Medical PLC
- FDA Inspection 939047 - 2015-06-24
- FDA Inspection 654385 - 2010-03-30
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