# FDA 483 - OSI Optoelectronics Inc. - October 18, 2023

Source: https://www.keypedia.com/records/483/osi-optoelectronics-inc/a1a59a81-2b23-4b35-b082-4fd768c0fd01

> FDA 483 for OSI Optoelectronics Inc. on October 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OSI Optoelectronics Inc.
- Inspection Date: 2023-10-18
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: OSI Optoelectronics Inc. in Hawthorne, CA, was inspected from October 11-18, 2023, and received one observation. The inspection revealed that the company failed to adequately document the results of design validation, specifically missing data sheets for DOLPHIN 2000 sensors, within its design history file. This indicates a deficiency in their design control and record-keeping practices for medical devices.

## Related Officers

- [Nancy Bogdanovic](https://www.keypedia.com/people/nancy-bogdanovic/acda7736-9cf7-46e0-ac7b-324fce8705bb)
- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.keypedia.com/companies/osi-optoelectronics-inc/3ff2744f-5ddd-461c-8ba7-9af03a4a2c5b

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