FDA Inspection
Stephen C. JensikStephen C. Jensik – FDA Inspection, Jun 9, 2016
Record Details
This FDA Inspection record concerns Stephen C. Jensik, with an inspection on June 9, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stephen C. Jensik
- Inspection Date
- June 9, 2016
- Product Type
- Biologics
View Company Profile
ID · 047a8eb9-92ce-42a1-91b1-a7a87e034ef0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 972742
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(c)Record retention
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