# FDA 483 - LV Liberty Vision - April 26, 2022

Source: https://www.globalkeysolutions.net/records/483/lv-liberty-vision/a8bf7c37-ad86-402b-acd0-afcaa7a6a621

> FDA 483 for LV Liberty Vision on April 26, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LV Liberty Vision
- Inspection Date: 2022-04-26
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: LV Liberty Vision, a medical device manufacturer in Portsmouth, NH, was cited for three significant quality system deficiencies. The inspection revealed inadequate design validation for their iWand P and Y-90 Disc, ineffective corrective and preventive action procedures, and a lack of established statistical techniques for process and product control. These issues indicate a need for improved quality management practices.

## Related Officers

- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.globalkeysolutions.net/companies/lv-liberty-vision/0c1a871d-aff2-4af9-ac31-c1db0eb40cda

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7