# FDA 483 - Cell Therapeutics Inc - November 18, 2009

Source: https://www.keypedia.com/records/483/cell-therapeutics-inc/2248d087-6b31-4b4c-a7d3-d6d991c8d84e

> FDA 483 for Cell Therapeutics Inc on November 18, 2009. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cell Therapeutics Inc
- Inspection Date: 2009-11-18
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Cell Therapeutics Inc in Seattle, WA, revealed a significant lapse in regulatory reporting for clinical trials. The firm failed to notify the FDA about the termination, for cause, of an investigator's participation in a clinical study. This indicates a deficiency in the firm's oversight and compliance with clinical investigation regulations.

## Related Officers

- [Anita Nalla](https://www.keypedia.com/people/anita-nalla/0a404841-cf37-4b60-8e08-9fb101b4afc3)
- [issuing_officer](https://www.keypedia.com/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)
- [James M. Kreis](https://www.keypedia.com/people/james-m-kreis/edd75dc2-0619-4b7f-a1e8-533fd4a1583a)

Company: https://www.keypedia.com/companies/cell-therapeutics-inc/bb319e69-b0aa-4fa0-af46-ebbe9481c498

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