FDA Inspection
Isto BiologicsIsto Biologics – FDA Inspection, Feb 18, 2011
Record Details
This FDA Inspection record concerns Isto Biologics, with an inspection on February 18, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Isto Biologics
- Inspection Date
- February 18, 2011
- Product Type
- Biologics
View Company Profile
ID · fd7041a2-5ad5-4302-9658-8b8234ad2823
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710391
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.320(c)Review and evaluation, report to FDA
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Isto Biologics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Isto Biologics
- FDA Inspection 1067144 - 2018-09-17
- FDA Inspection 786221 - 2012-06-15
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