# FDA 483 - Teirstein, Paul S. MD - August 17, 2015

Source: https://www.keypedia.com/records/483/teirstein-paul-s-md/04045c50-ece4-4a87-ad35-5958c2ee038a

> FDA 483 for Teirstein, Paul S. MD on August 17, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teirstein, Paul S. MD
- Inspection Date: 2015-08-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Paul S. Teirstein, MD, a clinical investigator in La Jolla, CA, was cited for significant deviations from investigational plans and informed consent requirements. The inspection revealed that subjects were enrolled despite not meeting inclusion/exclusion criteria and serious adverse events were not reported in a timely manner. Additionally, informed consent documents were not provided in a language understandable to non-English speaking subjects.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/allen-f-hall/31f65a8e-0de8-4f00-b9c1-12109ba3a0b2)
- [investigator](https://www.keypedia.com/people/natalie-j-ayoub/7dc2ef99-ae2e-45f1-8e7d-e8770e632035)

Company: https://www.keypedia.com/companies/teirstein-paul-s-md/4fdd374e-02d9-4fa8-8339-c744ea49175c

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