# FDA 483 - David L. Wirta, M.D. - August 13, 2021

Source: https://www.keypedia.com/records/483/david-l-wirta-md/ed0a8ac1-d487-454d-85bb-05fa843ff227

> FDA 483 for David L. Wirta, M.D. on August 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David L. Wirta, M.D.
- Inspection Date: 2021-08-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: David L. Wirta, M.D., a clinical investigator in Newport Beach, CA, was cited for failing to maintain adequate and accurate case histories during a human clinical study of an investigational drug. The firm did not report investigational drugs taken as concomitant medications in electronic case report forms for subjects enrolled in multiple studies. This issue impacts the integrity and accuracy of the clinical trial data.

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/david-l-wirta-md/f239b2b9-d44b-4aa0-b2e3-3506e3831bae

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