# FDA 483 - Peripheral Visions, Inc. - January 27, 2020

Source: https://www.globalkeysolutions.net/records/483/peripheral-visions-inc/a817187a-9d8a-4db1-80ed-0932474f80bf

> FDA 483 for Peripheral Visions, Inc. on January 27, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Peripheral Visions, Inc.
- Inspection Date: 2020-01-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Peripheral Visions, Inc. in Black Diamond, WA, a manufacturer of Class II electrodes, was inspected by the FDA from January 21-27, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established procedures for complaint handling, CAPA, nonconforming product, quality audits, process control, design control, device history records, purchasing control, document control, and training. Several observations were repeats, indicating a systemic failure to implement basic quality system requirements.

## Related Documents

- [483 - 2018-08-10](https://www.globalkeysolutions.net/records/483/peripheral-visions-inc/c8878e9a-711a-42e9-924f-4a83ea3f68a0)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/peripheral-visions-inc/8b8178c5-cd2d-4903-b0ef-54217e084d59

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822