FDA Inspection
William Philip Werschler, MD, FAAD, FAACSWilliam Philip Werschler, MD, FAAD, FAACS – FDA Inspection, Nov 29, 2017
Record Details
This FDA Inspection record concerns William Philip Werschler, MD, FAAD, FAACS, with an inspection on November 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Mark W. Babbitt (Issuing Officer)
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ID · f0cf3e8f-6464-46e4-bb6e-4599de4b4cc7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1032312
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(iii)Investigator records of disposition of devices inadequate
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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Other FDA inspections of William Philip Werschler, MD, FAAD, FAACS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for William Philip Werschler, MD, FAAD, FAACS
- FDA Inspection 1146966 - 2021-07-21
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