# FDA 483 - Thomas D. Coates, M.D. - August 02, 2019

Source: https://www.keypedia.com/records/483/thomas-d-coates-md/0c523f80-b535-486e-a5c5-99519a566cee

> FDA 483 for Thomas D. Coates, M.D. on August 02, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thomas D. Coates, M.D.
- Inspection Date: 2019-08-02
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Thomas D. Coates, M.D. in Los Angeles, CA, a clinical investigator, revealed significant deficiencies in the preparation and maintenance of adequate and accurate case histories. The inspection found issues with source records, including medical histories, adverse events, and concomitant medications, which lacked completeness, attributability, and proper dating for investigator signatures. These findings indicate a failure to maintain proper documentation for clinical investigations.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.keypedia.com/companies/thomas-d-coates-md/72c146ec-bc9b-42e9-8797-55f84fea2a47

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