# FDA 483 - Dwayne Logan, M.D. - August 01, 2023

Source: https://www.globalkeysolutions.net/records/483/dwayne-logan-md/acb14bca-6ab1-42fc-b0d5-6cb647032c91

> FDA 483 for Dwayne Logan, M.D. on August 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dwayne Logan, M.D.
- Inspection Date: 2023-08-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Dwayne K. Logan, M.D., a clinical investigator in Huntington Beach, CA, revealed significant deficiencies in record-keeping and adherence to investigational plans. The inspection found that original source records were missing for multiple subjects and visits, and serious adverse events were not reported to the sponsor or recorded in EDC in a timely manner. Additionally, investigations were not conducted in accordance with the signed statement of investigator and investigational plan.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/cheron-m-portee/c2cf139d-e4ce-400d-893e-bd733b3ec3a9)

Company: https://www.globalkeysolutions.net/companies/dwayne-logan-md/6b8c5532-9d67-4e81-8245-561906fdc6ef

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