# FDA WARNING_LETTER - Hsueh, Willa A., M.D. - October 09, 2007

Source: https://www.keypedia.com/records/warning_letter/hsueh-willa-a-md/667c31b5-e16f-4881-bffe-82e2ca91ce5e

> FDA WARNING_LETTER for Hsueh, Willa A., M.D. on October 09, 2007. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hsueh, Willa A., M.D.
- Inspection Date: 2007-10-09
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On September 4-October 9, 2007, the FDA inspected Dr. Willa A. Hsueh's conduct of two clinical investigations: Protocol #[redacted] ("Impact of Rosiglitazone on Cardiac Fibrosis...") and Protocol #[redacted] ("Effect on Glycemic Control of [redacted]..."). Dr. Hsueh was the sponsor-investigator for protocol #[redacted]. The inspection revealed non-adherence to FDA regulations governing clinical investigations and human subject protection.

Sponsor violations for protocol #[redacted] included:
1.  Failure to monitor the clinical investigation [21 CFR 312.56(a)].
2.  Failure to list sub-investigators (e.g., [redacted]) on Form FDA 1572 before starting the investigation [21 CFR 312.53(c)(1)(viii)].

Investigator violations for both protocols, primarily #[redacted], included:
1.  Failure to adequately supervise investigations [21 CFR 312.60], leading to other observations.
2.  Failure to ensure IRB compliance for initial/continuing review and approval, and failure to report changes promptly for IRB approval [21 CFR 312.66]. Specifically, protocol changes were implemented without IRB approval, and subjects were enrolled (e.g., [redacted]) when IRB approval had expired

## Related Officers

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Company: https://www.keypedia.com/companies/hsueh-willa-a-md/4646c4d8-0dc4-46f2-8f74-dc624e8654a4

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