FDA WARNING_LETTER - Whittier, Frederick M.D. - September 12, 2007

The FDA issued a Warning Letter to Dr. Frederick C. Whittier following an inspection conducted between August 22 and September 12, 2007. The inspection reviewed Dr. Whittier's conduct of clinical investigations for investigational drugs [redacted] and [redacted] across three protocols, as part of the Bioresearch Monitoring Program. The FDA concluded that Dr. Whittier failed to adhere to applicable statutory requirements and FDA regulations governing clinical investigations and human subject protection.

Key violations included the failure to conduct clinical investigations according to investigational plans (21 CFR 312.60). This involved enrolling multiple subjects who met exclusionary criteria in Protocols [redacted] and [redacted], enrolling a subject treated with oral antibiotics prior to baseline in Protocol [redacted], and failing to retest elevated liver enzymes within the protocol-specified timeframe for a subject in Protocol [redacted], potentially exposing them to harm.

Additionally, Dr. Whittier failed to maintain adequate and accurate case histories (21 CFR 312.62(b)). Deficiencies included retroactive changes to joint counts, discarding original pharmacokinetic (PK) sample preparation records and creating new ones with unverified information, backdating of source notes by a study coordinator not present, and inadequate record-keeping for PK sample processing. Dr. Whittier is required to respond within fifteen working days, outlining corrective actions to prevent future violations, with potential regulatory action if not adequately addressed.