# FDA 483 - Hycor Biomedical LLC - November 26, 2025

Source: https://www.keypedia.com/records/483/hycor-biomedical-llc/e710b9b7-9338-4f21-bd4a-d24598bd626d

> FDA 483 for Hycor Biomedical LLC on November 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hycor Biomedical LLC
- Inspection Date: 2025-11-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Hycor Biomedical LLC in Garden Grove, CA, was inspected by the FDA from November 19-26, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning complaint handling and corrective and preventive actions. The firm failed to adequately investigate complaints involving device specification failures and did not properly conduct or document root cause analyses for nonconformances.

## Related Documents

- [483 - 2025-11-26](https://www.keypedia.com/records/483/hycor-biomedical-llc/99829b28-0e79-401d-8cf1-7a1ae53ea7d9)

## Related Officers

- [Jae H. Lee](https://www.keypedia.com/people/jae-h-lee/ce701294-2a54-48f2-8a34-e93231bc2d88)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/hycor-biomedical-llc/153b80e1-a574-4ba4-a0ed-61545b610202

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