# FDA 483 - David Berz, M.D., Ph.D - January 14, 2025

Source: https://www.keypedia.com/records/483/david-berz-md-phd/bdcd75fa-f5ed-41f7-a39d-e6f8030f8300

> FDA 483 for David Berz, M.D., Ph.D on January 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David Berz, M.D., Ph.D
- Inspection Date: 2025-01-14
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of David Berz, M.D., Ph.D, a clinical investigator in Los Angeles, CA, from January 6-14, 2025, identified two significant observations. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including enrolling a subject who did not meet inclusion criteria. Additionally, the firm did not prepare or maintain adequate and accurate case histories, with discrepancies noted between source documents.

## Related Documents

- [EIR - 2025-01-14](https://www.keypedia.com/records/eir/david-berz-md-phd/40ea8fac-fc40-46ff-9a61-d2651661c8fc)

## Related Officers

- [Korina Serrano](https://www.keypedia.com/people/korina-serrano/c96035ff-7eb6-4049-ab6f-248c3c959c3b)
- [Jasmine Y. Wang](https://www.keypedia.com/people/jasmine-y-wang/e23c7335-477c-4671-8dcc-72e9149d424e)

Company: https://www.keypedia.com/companies/david-berz-md-phd/46d8f434-a167-470c-8c95-3a749fc9245a

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