# FDA 483 - Bioplate Inc - June 01, 2026

Source: https://www.keypedia.com/records/483/bioplate-inc/bab16bef-6181-4464-87bf-457c8085dc39

> FDA 483 for Bioplate Inc on June 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioplate Inc
- Inspection Date: 2026-06-01
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Bioplate Inc, a manufacturer of neurosurgical devices in Placentia, CA, was cited for significant deficiencies across its quality management system. Observations included inadequate risk management records, insufficient feedback process documentation, poor control over outsourced manufacturing, and deficient corrective and preventive action procedures. The firm also lacked process validation records for a relocated product line, indicating systemic issues in ensuring product conformity and safety.

## Related Officers

- [Linda Galindo](https://www.keypedia.com/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.keypedia.com/companies/bioplate-inc/e72bec43-f32d-43a9-9428-7be11cbe2e82

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