# FDA 483 - Jan L. Brandes, M.D. - October 18, 2019

Source: https://www.globalkeysolutions.net/records/483/jan-l-brandes-md/ad592398-9010-4a48-96f2-cdc37c3ac8cc

> FDA 483 for Jan L. Brandes, M.D. on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jan L. Brandes, M.D.
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Jan L. Brandes, M.D. at Nashville Neuroscience Group identified significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and contemporaneous case histories for enrolled subjects, leading to issues with data integrity and record-keeping. Additionally, the investigation was not conducted in accordance with the investigational plan, revealing problems with supervision, subject eligibility, and adherence to protocol requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/cheryl-a-grandinetti/db17fca7-6b39-48b9-a7f3-86817b56a9a1)
- [investigator](https://www.globalkeysolutions.net/people/ann-b-borromeo/ca03a531-043c-4195-b100-a8a0fc763159)

Company: https://www.globalkeysolutions.net/companies/jan-l-brandes-md/51ceda1c-ad81-4d04-aeb0-4df1c432b004

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea