FDA Inspection
Ronald F. Budzik Jr., MDRonald F. Budzik Jr., MD – FDA Inspection, Oct 17, 2017
Record Details
This FDA Inspection record concerns Ronald F. Budzik Jr., MD, with an inspection on October 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 62b1da68-6ca8-442d-9b92-8807317dfeec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028855
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
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Other FDA inspections of Ronald F. Budzik Jr., MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Ronald F. Budzik Jr., MD
- FDA Inspection 1118258 - 2020-01-16
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