Company
SwedenElos Medtech Skara AB, Skara, Sweden – FDA Inspections
Inspection records and compliance data for Elos Medtech Skara AB in Skara. 2 FDA inspections on record, 1 Form 483, last inspected August 31, 2023.
Company Profile
This profile covers Elos Medtech Skara AB based in Skara, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 23, 2018. Last inspected August 31, 2023.
Most cited issue areas
- Equipment control activity documentation1 inspection
- Lack of Written MDR Procedures1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1220692 |
| March 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1047590 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elos Medtech Skara AB
FEI Number
3012416874
Address
Hasthagsgatan 2, Skara, Sweden
Country
Sweden
ID: 81bbce1f-6f6d-41a8-a1e6-369490c7c854