# FDA 483 - Milind Javle, MD - December 21, 2020

Source: https://www.keypedia.com/records/483/milind-javle-md/d0ecb325-9063-412f-b063-de60126d9eab

> FDA 483 for Milind Javle, MD on December 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milind Javle, MD
- Inspection Date: 2020-12-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Milind Javle, MD, a clinical investigator in Houston, TX, was cited for significant deficiencies during an FDA inspection. Observations included lapses in IRB continuing review, failure to adhere to the investigational plan for subject procedures, and critical failures in obtaining informed consent and timely reporting of serious adverse events to the sponsor. These issues indicate a lack of control over key aspects of clinical trial conduct and subject protection.

## Related Officers

- [investigator](https://www.keypedia.com/people/zerita-white/82b19f0c-bd17-4a44-8523-8986f38851a8)

Company: https://www.keypedia.com/companies/milind-javle-md/2afb0ef5-7c87-4b58-9cf8-6802dbeeca52

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab