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

Source: https://www.keypedia.com/records/warning_letter/hilton-becker-md/3f156a54-dfee-44c8-85e6-860ae4ebf7db

> FDA WARNING_LETTER for Hilton Becker, MD on November 21, 2007. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hilton Becker, MD
- Inspection Date: 2007-11-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)

Company: https://www.keypedia.com/companies/hilton-becker-md/ff6aedb3-d0f5-48b3-89ad-47e4709ed1de

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7