# Linda Glaser – FDA 483, Sep 20, 2010

Source: https://www.keypedia.com/records/483/linda-glaser/02f0a1d2-0da0-427d-8853-9e5f62943026

> FDA 483 for Linda Glaser on September 20, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linda Glaser
- Inspection Date: 2010-09-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Coastal Biomedical Research, Inc. in Santa Monica, CA, was cited for significant deficiencies during an FDA inspection of its clinical trial operations. The firm failed to maintain adequate investigational drug disposition records, exhibited multiple protocol deviations, and did not ensure accurate case histories for study subjects. These issues indicate serious concerns regarding data integrity and adherence to clinical trial regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/terri-l-thomas/64ff3727-20db-4c43-a1b5-7cd653f95f32)

Company: https://www.keypedia.com/companies/linda-glaser/9d6c9c98-4c36-49b5-8c39-f9194b35832f

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