FDA Inspection
ENERGIST LIMITEDENERGIST LIMITED – FDA Inspection, May 24, 2012
Record Details
This FDA Inspection record concerns ENERGIST LIMITED, with an inspection on May 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ENERGIST LIMITED
- Inspection Date
- May 24, 2012
- Product Type
- Devices
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ID · 4e62a19c-cba4-4fef-9cf2-4e8a0c2a33eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 785656
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ENERGIST LIMITED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| September 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ENERGIST LIMITED
- FDA Inspection 1257682 - 2024-12-05
- FDA Inspection 1018532 - 2017-07-20
- FDA Inspection 898412 - 2014-09-18
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