FDA Inspection
Lightmed USA IncLightmed USA Inc – FDA Inspection, Jun 27, 2017
Record Details
This FDA Inspection record concerns Lightmed USA Inc, with an inspection on June 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 7ad7d985-6355-4be2-b967-a269699b4c3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lightmed USA Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lightmed USA Inc
- FDA Inspection 1217913 - 2023-08-09
- FDA Inspection 580472 - 2009-01-28
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.