FDA Inspection
Sunmed AP, Ltd.Sunmed AP, Ltd. – FDA Inspection, Mar 5, 2026
Record Details
This FDA Inspection record concerns Sunmed AP, Ltd., with an inspection on March 5, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 834aef8a-923f-4d94-bdfa-032113e2be11
Inspection Facts
- Inspection number
- 1311202
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 807.40(a)Failure to register
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunmed AP, Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 30, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunmed AP, Ltd.
- FDA Inspection 977038 - 2016-03-31
- FDA Inspection 843271 - 2013-05-30
- FDA Inspection 657579 - 2010-03-04
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.