FDA WARNING_LETTER - Mancha, Vaughn H Jr, M. D. - September 23, 2010

This FDA Warning Letter, dated February 17, 2011, addresses Dr. Vaughn H. Mancha, Jr. following an FDA inspection conducted between September 7 and September 23, 2010. The inspection reviewed Dr. Mancha's conduct of a clinical investigation (Protocol (b)(4)) of the investigational drug (b)(4) for (b)(4), as part of FDA's Bioresearch Monitoring Program.

The letter concludes that Dr. Mancha failed to adhere to statutory requirements and FDA regulations governing clinical investigations, specifically 21 CFR 312.60 and 21 CFR 312.62(b).

Key violations include:

1. **Failure to ensure investigation conducted according to investigational plan [21 CFR 312.60]:** * **Delayed and inaccurate SAE reporting for Subject #389204:** Acute renal failure was not reported to the CRO within 24 hours (reported Feb 27, 2008, despite awareness on Feb 20, 2008), and the onset date was misrepresented. No adequate corrective actions were provided for timely and accurate reporting. * **Delayed laboratory result review for Subject #389062:** Laboratory results received October 10, 2007, were not documented as reviewed until April