FDA WARNING_LETTER - Toledo, Charles H., M.D. - September 30, 2009

An FDA inspection conducted between August 3, 2009, and September 30, 2009, at Western North Carolina Pediatric and Adolescent Care, reviewed Dr. Charles H. Toledo's conduct of clinical studies (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified violations of 21 CFR Part 312 concerning investigational new drugs.

Key violations include: 1. **Failure to ensure investigation conducted according to protocol and regulations (21 CFR § 312.60):** * **Study 1:** Numerous adverse events and concomitant medications were not reported in subjects' eCRFs as required by the protocol. Attempts to contact subjects who dropped from the study were delayed. One subject who met elimination criteria (received an unapproved vaccine) was continued in the study. * **Study 2:** Study vaccines were administered by unauthorized individuals. 2. **Failure to maintain adequate and accurate case histories (21 CFR § 312.62(b)):** * **Study 1:** Adverse events, new medically significant events, and concomitant medications from medical records were not reported in eCRFs. Discrepancies existed between source documents and eCRFs/drug accountability records. An elimination criterion was not reported in the eCRF until much later. * **Study 2:** Discrep