FDA Inspection
ENERGIST LIMITEDENERGIST LIMITED – FDA Inspection, Jul 20, 2017
Record Details
This FDA Inspection record concerns ENERGIST LIMITED, with an inspection on July 20, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · ccf83383-b98a-4737-a5a5-1b03299a33b0
Inspection Facts
- Inspection number
- 1018532
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of ENERGIST LIMITED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 24, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ENERGIST LIMITED
- FDA Inspection 1257682 - 2024-12-05
- FDA Inspection 898412 - 2014-09-18
- FDA Inspection 785656 - 2012-05-24
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