# FDA 483 - Kevin B. Kim, Clinical Investigator - October 16, 2013

Source: https://www.globalkeysolutions.net/records/483/kevin-b-kim-clinical-investigator/58179df4-691f-4861-9d9b-8b7f89e06e3f

> FDA 483 for Kevin B. Kim, Clinical Investigator on October 16, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kevin B. Kim, Clinical Investigator
- Inspection Date: 2013-10-16
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Kevin B. Kim, Clinical Investigator in Houston, TX, revealed significant deficiencies in clinical trial conduct. The observations included failures to obtain proper informed consent, deviations from the investigational plan, and inadequate investigational drug disposition records. These issues indicate a lack of adherence to regulatory requirements for human subject protection and clinical study management.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/kevin-b-kim-clinical-investigator/b28d1777-df6d-4b88-b00b-d9c34870c43d

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9