# FDA WARNING_LETTER - Thomas S. Tooma, M.D. - July 17, 2015

Source: https://www.keypedia.com/records/warning_letter/thomas-s-tooma-md/ca72a799-9cdc-406f-a593-f6c9edca0e54

> FDA WARNING_LETTER for Thomas S. Tooma, M.D. on July 17, 2015. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Thomas S. Tooma, M.D.
- Inspection Date: 2015-07-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On November 2, 2015, the FDA issued a Warning Letter to Thomas S. Tooma, M.D., of NVISION Laser Eye Centers, following an inspection from June 29 to July 17, 2015. The inspection reviewed Dr. Tooma's conduct as sponsor-investigator for the "Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 in Eyes with Keratoconus or Ectasia," involving investigational riboflavin ophthalmic solution (0.1% and 0.25%).

The FDA identified three significant violations:
1.  **Failure to Submit an IND:** Dr. Tooma failed to submit an Investigational New Drug (IND) application for the riboflavin ophthalmic solution, which is considered a drug under the FD&C Act and was not lawfully marketed or exempt from IND requirements. The study, initiated in September 2012, enrolled subjects at a minimum of seven sites. Dr. Tooma's response, citing lack of awareness and humanitarian use, was deemed inadequate as no IND had been submitted.
2.  **Failure to Ensure Proper Monitoring:** Dr. Tooma failed to ensure proper monitoring of the clinical investigation, acknowledging he did not have a monitor. His proposed plan to hire an experienced monitor was inadequate due to lack of a timeline and specific details.
3

## Related Officers

- [Director ](https://www.keypedia.com/people/david-c-burrow/ad3d9e72-84f5-464c-8760-0f55d2fd7ca6)

Company: https://www.keypedia.com/companies/thomas-s-tooma-md/20d88cf1-f101-431c-a5a5-841458d80da6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c