# FDA 483 - Lakhi Sakhrani - February 05, 2016

Source: https://www.keypedia.com/records/483/lakhi-sakhrani/35f01ede-07c8-4b96-9e0c-778b5018df0c

> FDA 483 for Lakhi Sakhrani on February 05, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lakhi Sakhrani
- Inspection Date: 2016-02-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Lakhi Sakhrani, a clinical investigator in San Gabriel, CA, revealed significant deficiencies in conducting clinical investigations and maintaining accurate records. Observations included failure to follow the investigational plan, such as not reporting required lab results due to samples exceeding stability and not suspending subject dosing as instructed. Additionally, widespread inaccuracies and omissions were found in case histories, concomitant medication reporting, adverse event reporting, and study drug accountability within the eCRF system.

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/lakhi-sakhrani/8e344c52-0425-4f0f-990c-26c9cf9e1b83

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6