FDA WARNING_LETTER - Corces, Arturo, M.D. - April 26, 2007

The FDA issued a Warning Letter to Dr. Arturo Corces following an inspection from March 20 to April 26, 2007, regarding two clinical investigations for orthopedic surgery. The inspection, part of FDA's Bioresearch Monitoring Program, found that Dr. Corces failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection.

Key violations include: 1. **Failure to Personally Conduct or Supervise (21 CFR 312.60):** Dr. Corces delegated protocol-specified clinical evaluations (e.g., physical examinations, DVT/PE assessments) to unqualified personnel, specifically a data entry individual, who performed these tasks even when Dr. Corces was absent. 2. **Inadequate Informed Consent (21 CFR 50.20):** Consent forms were not consistently provided in a language understandable to subjects, and documentation of bilingualism was missing. Some consent forms had incomplete sections or lacked signatures for the individual discussing consent. 3. **Failure to Adhere to Protocols (21 CFR 312.60):** Numerous protocol deviations were identified, including missed follow-up visits, unauthorized use of pneumatic compression therapy (explicitly prohibited), administration of excluded concomitant medications (e.g., Plavix, aspirin) within the prohibited timeframe, unauthorized coagulation testing, inadequate documentation of "not clinically significant" lab values, incorrect timing of blood draws, and failure