FDA Inspection
Vesco Medical LlcVesco Medical Llc – FDA Inspection, Oct 31, 2023
Record Details
This FDA Inspection record concerns Vesco Medical Llc, with an inspection on October 31, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · da8cca13-d4c8-437d-8952-8cdaabb704c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222433
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vesco Medical Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vesco Medical Llc
- FDA Inspection 1022540 - 2017-08-09
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.