Hilton Becker, MD – FDA Warning Letter, Nov 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