# FDA WARNING_LETTER - Houser, Elizabeth E. MD - January 06, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/houser-elizabeth-e-md/66002b94-ab14-487c-8017-1ecc9a97a918

> FDA WARNING_LETTER for Houser, Elizabeth E. MD on January 06, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Houser, Elizabeth E. MD
- Inspection Date: 2011-01-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This Warning Letter to Dr. Elizabeth E. Houser details objectionable conditions observed during an FDA inspection from December 6, 2010, to January 6, 2011, concerning clinical investigations of flibanserin (Protocols #511.75 and #511.84) for Boehringer Ingelheim Pharmaceuticals.

The FDA concluded that Dr. Houser did not adhere to statutory requirements and FDA regulations. Key violations include:

1.  **Submission of False Information [21 CFR 312.70(a)]**: For Protocol 511.84, Clinical Global Impression (CGI) of Severity and CGI of Efficacy Index assessments for Subject 27881 (Visits 2, 4, 5, 6, and 7) were falsely attributed to a sub-investigator by the study coordinator, who did not conduct them. This compromises study integrity and data reliability.

2.  **Failure to Conduct Investigation According to Plan [21 CFR 312.60]**:
    *   **Off-site Visits and Unqualified Assessors**: For Subject 27881, Visits 2, 4, 5, 6, and 7 were conducted off-site, contrary to protocol. Additionally, CGI assessments for these visits were performed by the study coordinator, who lacked the required credentials (D

## Related Officers

- [Leslie K. Ball](https://www.globalkeysolutions.net/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)

Company: https://www.globalkeysolutions.net/companies/houser-elizabeth-e-md/ceeb8680-81fb-4f51-b39a-e72618388421

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