FDA Inspection
Stembanc IncStembanc Inc – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns Stembanc Inc, with an inspection on February 12, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stembanc Inc
- Inspection Date
- February 12, 2014
- Product Type
- Biologics
View Company Profile
ID · 05432b6a-b44b-4c03-b2c3-a50e23f7025e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862242
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.80(a)Birth mother sample not tested
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.230(a)Validation & approval--established procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stembanc Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 4, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 27, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 31, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Stembanc Inc
- FDA Inspection 1242190 - 2024-06-06
- FDA Inspection 1153328 - 2021-09-23
- FDA Inspection 814359 - 2013-02-04
- FDA Inspection 659051 - 2010-04-27
- FDA Inspection 596205 - 2009-08-31
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