# FDA WARNING_LETTER - Gazda, Thomas M.D. - February 06, 2009

Source: https://www.keypedia.com/records/warning_letter/gazda-thomas-md/aafd4366-3cb9-4289-ac42-fc3631248cf1

> FDA WARNING_LETTER for Gazda, Thomas M.D. on February 06, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Gazda, Thomas M.D.
- Inspection Date: 2009-02-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 20-February 6, 2009, the FDA inspected Dr. Thomas Gazda's conduct of a clinical investigation (b)(4) of the investigational drug (b)(4) for (b)(4). The inspection revealed non-adherence to statutory requirements and FDA regulations governing clinical investigations.

The FDA identified two primary violations:
1.  **Failure to conduct the investigation according to the investigational plan [21 CFR 312.60]:**
    *   Informed consent was not obtained by qualified personnel (M.D., Ph.D., or RN) or approved by (b)(4) for all subjects (1001-1008, 1010-1013).
    *   Incorrect diagnostic instrument ((b)(4) instead of (b)(4)) was used for subjects 1008, 1010, 1011, 1012, and 1013.
    *   (b)(4) was administered by a study coordinator, not the principal or sub-investigator, for subjects 1001-1007, and no documentation of rater-qualification training existed.
    *   Daily subject/parent contact for monitoring was not documented for 10 of 11 subjects.
    *   Subject 101

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Company: https://www.keypedia.com/companies/gazda-thomas-md/b2437694-bb60-40c2-af32-954bd6c13c61

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