FDA Inspection
Prof. Jerzy Tadeusz HofmanProf. Jerzy Tadeusz Hofman – FDA Inspection, Jun 11, 2013
Record Details
This FDA Inspection record concerns Prof. Jerzy Tadeusz Hofman, with an inspection on June 11, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Prof. Jerzy Tadeusz Hofman
- Inspection Date
- June 11, 2013
- Product Type
- Biologics
View Company Profile
ID · 717ed464-7c20-49f7-8afc-a0a9694d8e0e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836078
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.120(c)Foreign clinical trials
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(c)Record retention
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