FDA Inspection
AB MEDICA SASFDA Inspection 1236059 - AB MEDICA SAS - March 28, 2024
Record Details
This FDA Inspection record concerns AB MEDICA SAS, with an inspection on March 28, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · b0e9b410-2035-4abd-aa56-4b9eb908b359
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236059
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AB MEDICA SAS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AB MEDICA SAS
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.