Company
United KingdomENERGIST LIMITED, Swansea, United Kingdom – FDA Inspections
Inspection records and compliance data for ENERGIST LIMITED in Swansea. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 05, 2024.
Company Profile
This profile covers ENERGIST LIMITED based in Swansea, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected May 24, 2012. Last inspected December 5, 2024.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1257682 |
| July 20, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1018532 |
| September 18, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 898412 |
| May 24, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 785656 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ENERGIST LIMITED
FEI Number
3007353760
Address
2 Park Pavilions, Clos Llyn Cwm; West, Swansea, United Kingdom
Country
United Kingdom
ID: 81a44614-5d5d-4c14-b7ad-2dfc509328f7