# Scantibodies Laboratory, Inc. – FDA 483, Jul 2, 2026

Source: https://www.keypedia.com/records/483/scantibodies-laboratory-inc/07daa7d2-6891-4faf-bd0d-2a237d7c3c59

> FDA 483 for Scantibodies Laboratory, Inc. on July 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scantibodies Laboratory, Inc.
- Inspection Date: 2026-07-02
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Scantibodies Laboratory, Inc. in Santee, CA, was cited for failing to determine donor eligibility before collecting source plasma during an inspection from June 29 to July 2, 2026. The firm collected plasma without valid informed consent or completed donor history questionnaires, indicating a significant lapse in donor screening procedures. This issue affected numerous donations over several years, impacting products for devices.

## Related Officers

- [James A. Banks](https://www.keypedia.com/people/james-a-banks/6838e911-c630-4a7c-8198-f3936ef6c5f8)
- [Abby L. Mozeke](https://www.keypedia.com/people/abby-l-mozeke/ce4ecbbc-0108-483e-aff3-d5320e50114f)

Company: https://www.keypedia.com/companies/scantibodies-laboratory-inc/87cffccc-0129-4ca1-b942-54c86ecde06f

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b