FDA inspection

ENERGIST LIMITED: FDA inspection ending Jul 20, 2017

FDA inspection 1018532 · Voluntary Action Indicated (VAI) · Swansea

Key facts

Inspection ID	1018532
Firm	ENERGIST LIMITED
FEI number	3007353760
Address	2 Park Pavilions, Clos Llyn Cwm; West
City	Swansea
Fiscal year	2017
Inspection end date	Jul 20, 2017
Classification	Voluntary Action Indicated (VAI)
Project area	Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority
Product type	Devices

At a glance

1–9 Citations
1–9 Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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