Company
SwedenHertART ApS, Vastra Frolunda, Sweden – FDA Inspections
Inspection records and compliance data for HertART ApS in Vastra Frolunda. 3 FDA inspections on record, 1 Form 483, last inspected August 28, 2023.
Company Profile
This profile covers HertART ApS based in Vastra Frolunda, Sweden.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 29, 2015. Last inspected August 28, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 28, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1220574 |
| March 21, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1047589 |
| April 29, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 927679 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HertART ApS
FEI Number
3008524469
Address
Gustaf Werners Gata 2, Vastra Frolunda, Sweden
Country
Sweden
ID: a8996873-2ce8-4b77-8863-d47f3b795828