# FDA 483 - Dr. Manish Butte, M.D. - October 24, 2025

Source: https://www.keypedia.com/records/483/dr-manish-butte-md/10ac880f-074a-4886-93e2-262c1c51222f

> FDA 483 for Dr. Manish Butte, M.D. on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Manish Butte, M.D.
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA Form 483 was issued to Dr. Manish Butte, M.D., a clinical investigator, following an inspection conducted from October 20-24, 2025. The inspection identified critical deviations from regulatory requirements regarding clinical study conduct and data integrity, under the scope of the Federal Food, Drug and Cosmetic Act. The primary observation cited was a failure to conduct the investigation in accordance with the approved investigational plan. This included not performing protocol-required Hepatitis, HIV, and Tuberculosis testing for a subject who would have been excluded from the study based on potential results, and omitting a specific (b)(4) test for another subject at required visits. Further issues involved the failure to report non-serious adverse events to the study sponsor within the established protocol timetable. Numerous adverse events, such as nausea, stomach pain, and various skin conditions, were not documented and submitted as required for multiple subjects. Additionally, the inspection noted a failure to maintain adequate and accurate case histories, specifically regarding the non-reporting of concomitant medications for all study subjects to the sponsor. The firm is expected to address these deficiencies with corrective actions to ensure compliance with FDA regulations.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/farwa-z-razvi/4ac4d0de-addf-4657-8756-0676015cea8a)

Company: https://www.keypedia.com/companies/dr-manish-butte-md/945f2812-bb44-4814-908d-69974255a263

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