Company
FranceAnalytic Biosurgical Solutions (ABISS), Saint-Etienne, France – FDA Inspections
Inspection records and compliance data for Analytic Biosurgical Solutions (ABISS) in Saint-Etienne, Loire. 2 FDA inspections on record, 1 Form 483, last inspected September 12, 2024.
Company Profile
This profile covers Analytic Biosurgical Solutions (ABISS) based in Saint-Etienne, Loire, France.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 31, 2018. Last inspected September 12, 2024.
Most cited issue areas
- Process changes - review, evaluation and revalidation1 inspection
- Review and evaluation for investigation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1251898 |
| May 31, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1055592 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Analytic Biosurgical Solutions (ABISS)
FEI Number
3004756681
Address
14 Rue De La Telematique, Saint-Etienne, Loire 42000, France
Country
France
ID: cd801490-5055-4784-b73e-863dd8ba50ad