FDA Inspection
BioEden IncBioEden Inc – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns BioEden Inc, with an inspection on July 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 31d4ffca-fe88-46df-87b7-c6458266806f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059476
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of BioEden Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for BioEden Inc
- FDA Inspection 763386 - 2012-01-18
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