FDA Inspection
Vela Operations USA, Inc.Vela Operations USA, Inc. – FDA Inspection, Jun 1, 2022
Record Details
This FDA Inspection record concerns Vela Operations USA, Inc., with an inspection on June 1, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vela Operations USA, Inc.
- Inspection Date
- June 1, 2022
- Product Type
- Devices
View Company Profile
ID · 4099d297-39ad-4d9d-a3e2-545216a7d121
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1170884
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vela Operations USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 7, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Vela Operations USA, Inc.
- FDA Inspection 909337 - 2015-01-07
- FDA Inspection 820021 - 2013-02-27
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