# FDA 483 - Capstone Clinical Trials, Inc. - February 17, 2026

Source: https://www.globalkeysolutions.net/records/483/capstone-clinical-trials-inc/6f7d0f2f-7df5-4c11-be8c-43732561366b

> FDA 483 for Capstone Clinical Trials, Inc. on February 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Capstone Clinical Trials, Inc.
- Inspection Date: 2026-02-17
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Capstone Clinical Trials, Inc. in Birmingham, AL, received a Form FDA 483 with five observations related to clinical trial conduct. The inspection revealed issues including inadequate documentation for subject unblinding, lack of IRB approval for off-site study activities and subject reimbursement, and discrepancies in study closure reporting. Additionally, the firm failed to accurately document delegation of duties and did not adhere to the protocol for subject randomization.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/patricia-smith/5c461f28-4b30-40ed-aa23-e8d4a8c4ab38)

Company: https://www.globalkeysolutions.net/companies/capstone-clinical-trials-inc/0025ba7f-7196-4fcd-bdb7-17e2d381fa36

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