FDA Inspection
Rolando Garcia, Jr., MDRolando Garcia, Jr., MD – FDA Inspection, May 10, 2013
Record Details
This FDA Inspection record concerns Rolando Garcia, Jr., MD, with an inspection on May 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rolando Garcia, Jr., MD
- Inspection Date
- May 10, 2013
- Product Type
- Devices
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ID · 92059a4b-0384-42f3-a2db-3a871ca4ec56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831757
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rolando Garcia, Jr., MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Rolando Garcia, Jr., MD
- FDA Inspection 765661 - 2012-01-20
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