# FDA 483 - Blink Device Company, LLC - October 15, 2021

Source: https://www.keypedia.com/records/483/blink-device-company-llc/3c736e17-8f8d-4f42-af42-591811bb35a5

> FDA 483 for Blink Device Company, LLC on October 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blink Device Company, LLC
- Inspection Date: 2021-10-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Blink Device Company, LLC, a medical device manufacturer in Seattle, WA, received a Form FDA 483 with four observations during an inspection. The firm was cited for inadequate establishment and implementation of procedures related to complaint handling, corrective and preventive actions (CAPA), design verification, and document control. These findings indicate significant deficiencies in the company's quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/blink-device-company-llc/e3fbd2e2-6741-4c74-af88-c106346f7a0a

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