# FDA 483 - Pegasus Research Corporation - February 21, 2020

Source: https://www.keypedia.com/records/483/pegasus-research-corporation/5cf70a42-e090-4709-a17e-cd952bff8f8e

> FDA 483 for Pegasus Research Corporation on February 21, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pegasus Research Corporation
- Inspection Date: 2020-02-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Pegasus Research Corporation, a medical device manufacturer in Santa Ana, CA, revealed significant quality system deficiencies. The firm lacked adequate procedures for design validation, environmental controls for aseptic assembly, and equipment calibration. Additionally, personnel training was undocumented, Medical Device Reporting procedures were incomplete, and internal quality audits were conducted by individuals with direct responsibility for the audited areas.

## Related Documents

- [483 - 2021-04-07](https://www.keypedia.com/records/483/pegasus-research-corporation/db480280-cf3c-46d5-b2c1-03983de244fc)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

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