# FDA 483 - Stephen A. Tilles, M.D. - October 31, 2019

Source: https://www.globalkeysolutions.net/records/483/stephen-a-tilles-md/92b8baeb-4aca-4beb-ba18-f7d818318a11

> FDA 483 for Stephen A. Tilles, M.D. on October 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stephen A. Tilles, M.D.
- Inspection Date: 2019-10-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: The FDA inspected Seattle Allergy and Asthma Research Institute, a clinical investigator, and found significant deviations from investigational plans and good clinical practices. Observations included numerous instances of study procedures not being followed, such as incorrect drug dosing, unapproved protocol changes, and missed visits. Additionally, the firm failed to maintain accurate case histories, including the use of altered informed consent forms, and lacked adequate investigational drug accountability records.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/stephen-a-tilles-md/1da35e49-8295-4a1c-a636-26e1d0b50687

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