# FDA 483 - Meddev Corp - February 28, 2022

Source: https://www.keypedia.com/records/483/meddev-corp/d930f92f-c632-4705-9540-7bc35461528c

> FDA 483 for Meddev Corp on February 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meddev Corp
- Inspection Date: 2022-02-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: MedDev Corporation, a medical device manufacturer in Sunnyvale, CA, was issued a Form FDA 483 with five observations following an inspection. The inspection revealed significant deficiencies across its quality system, including inadequate documentation for corrective and preventive actions, a lack of regular management reviews and internal audits, and poorly maintained complaint files. Additionally, the firm failed to adequately document personnel training, indicating systemic issues in maintaining an effective quality system.

## Related Documents

- [483 - 2025-03-12](https://www.keypedia.com/records/483/meddev-corp/d8a2f3a8-2ea3-49f8-884c-ebc4844488d8)

## Related Officers

- [Eileen M. Malecki](https://www.keypedia.com/people/eileen-m-malecki/775204bb-a174-4bf9-93dc-03c300f81af0)

Company: https://www.keypedia.com/companies/meddev-corp/f0dc12f6-71b1-431d-b69a-72403f16e212

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b