# FDA 483 - Shailender Bhatia - November 30, 2016

Source: https://www.keypedia.com/records/483/shailender-bhatia/eaff09a3-649d-45fb-9664-3a395fe78f98

> FDA 483 for Shailender Bhatia on November 30, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Shailender Bhatia
- Inspection Date: 2016-11-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Dr. Shailender Bhatia, a clinical investigator in Seattle, WA, was inspected by the FDA from November 16-30, 2016. The inspection revealed that the clinical investigation was not conducted in accordance with the signed statement of investigator and investigational plan. This included failures to report serious adverse events to the sponsor within the specified timeframe and to perform required post-infusion ECG assessments for multiple subjects.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)

Company: https://www.keypedia.com/companies/shailender-bhatia/e40857a8-9793-4626-af15-5df61950f33a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822