Company
SpainTranscendencias Comerciales S.L., San Sebastian, Donostia, Spain – FDA Inspections
Inspection records and compliance data for Transcendencias Comerciales S.L. in San Sebastian, Donostia. 2 FDA inspections on record, 2 Form 483s, last inspected July 26, 2018.
Company Profile
This profile covers Transcendencias Comerciales S.L. based in San Sebastian, Donostia, Spain.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 18, 2016. Last inspected July 26, 2018.
Most cited issue areas
- Design history file1 inspection
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2018 | Not classified | Medical Devices & Rad Health | 1136100 |
| October 18, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 991810 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Transcendencias Comerciales S.L.
FEI Number
3005346382
Address
Edif Urumea - Finca 1, Planta Baja, Loca, San Sebastian, Donostia, Spain
Country
Spain
ID: 024e9389-dec5-4026-9c8f-096afdc84013