FDA Inspection
Oxigene, Inc.Oxigene, Inc. – FDA Inspection, Mar 1, 2012
Record Details
This FDA Inspection record concerns Oxigene, Inc., with an inspection on March 1, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oxigene, Inc.
- Inspection Date
- March 1, 2012
- Product Type
- Drugs
View Company Profile
ID · db682fcc-f3dc-4e6d-b51a-1a7414482553
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771696
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.53(d)Selecting monitors
- 21 CFR 312.57(c)Record retention requirement
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