FDA Inspection
Heffner, John, Clinical InvestigatorHeffner, John, Clinical Investigator – FDA Inspection, Feb 22, 2010
Record Details
This FDA Inspection record concerns Heffner, John, Clinical Investigator, with an inspection on February 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 22, 2010
- Product Type
- Biologics
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ID · 57585a86-34a2-4a32-8651-b3c1493270d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649647
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
- 21 CFR 812.140(a)(2)(iii)Investigator records of disposition of devices inadequate
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Other FDA inspections of Heffner, John, Clinical Investigator
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2008 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Heffner, John, Clinical Investigator
- FDA Inspection 550842 - 2008-12-05
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