FDA WARNING_LETTER - Hilton Becker, MD - November 21, 2007

This FDA Warning Letter to Dr. Hilton Becker details objectionable conditions observed during an inspection from October 30 to November 21, 2007, concerning his participation in the [redacted] Study (IDE [redacted]) and [redacted] Study, both sponsored by [redacted]. The inspection aimed to ensure compliance with federal regulations for investigational device exemptions (21 CFR Part 812) and protect human subjects.

Key violations include: 1. **Failure to maintain accurate, complete, and current records (21 CFR 812.140(a))**: * No device accountability or inventory records for the [redacted] Study, lacking details like complete dates, patient numbers, and device serial/catalog numbers. Shipping records for devices were also missing. * Inaccurate and incomplete subject case histories, including conflicting device serial numbers for Subject [redacted], incorrect catalog/reference numbers for implanted devices, and no documentation of eligibility evaluations for any reviewed subjects in the [redacted] Study.

2. **Failure to ensure investigation conducted per agreement/plan (21 CFR 812.100, 21 CFR 812.110(b))**: * Consent forms for the [redacted] Study lacked required witness signatures. * Inadequate or missing device accountability, subject enrollment, and source records, contrary