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

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