# Orca Biosystems, Inc. – FDA 483, Sep 20, 2026

Source: https://www.keypedia.com/records/483/orca-biosystems-inc/04eff70d-5649-4ca0-8c36-7b647f550a70

> FDA 483 for Orca Biosystems, Inc. on September 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orca Biosystems, Inc.
- Inspection Date: 2026-09-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Orca Biosystems, Inc. in Sacramento, California, revealed significant deficiencies in laboratory controls for their Hematopoietic Stem and Progenitor Cell (HSPC), Regulatory T Cell (Treg), and Conventional T Cell (Tcon) drug products. Specifically, quality control assay procedures, standard operating procedures, and work instructions lacked detailed steps and adequate controls, rendering release testing results unreliable and irreproducible. These issues could compromise product quality decisions and patient safety.

## Related Officers

- [Hector A. Carrero](https://www.keypedia.com/people/hector-a-carrero/d696704e-1309-4f01-8f1e-a2b2b639f881)
- [Karin Knudsen BioRev](https://www.keypedia.com/people/karin-knudsen-biorev/1c20569f-6104-4e93-9751-5234752f31c8)
- [Elizabeth Lemer-Morillon, Senior Biologist](https://www.keypedia.com/people/elizabeth-lemer-morillon-senior-biologist/5bbbc2a9-3a3a-4b0f-958a-949fb63854db)
- [Sarah E. Underwood](https://www.keypedia.com/people/sarah-e-underwood/8b88f29c-cd5e-4a70-95b5-2968b7036098)
- [Saravanan Karunakaran, Biologist](https://www.keypedia.com/people/saravanan-karunakaran-biologist/62ad7a61-c13c-40fe-b6be-4c4e91b54271)

Company: https://www.keypedia.com/companies/orca-biosystems-inc/7b34a3b2-3860-4cd3-9854-15c809a28414

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4