# FDA 483 - Pegasus Research Corporation - April 07, 2021

Source: https://www.keypedia.com/records/483/pegasus-research-corporation/db480280-cf3c-46d5-b2c1-03983de244fc

> FDA 483 for Pegasus Research Corporation on April 07, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pegasus Research Corporation
- Inspection Date: 2021-04-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pegasus Research Corporation in Santa Ana, CA, was inspected regarding its manufacturing practices. The inspection revealed significant deficiencies in the firm's design control procedures, specifically the lack of validation, verification, and review for design changes to its Nebulizer Heater Adaptor Top. This indicates a serious lapse in quality system requirements for medical device manufacturing.

## Related Documents

- [483 - 2020-02-21](https://www.keypedia.com/records/483/pegasus-research-corporation/5cf70a42-e090-4709-a17e-cd952bff8f8e)

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/pegasus-research-corporation/78297643-ca4c-43d1-ba62-3cdc3fa642b9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6