FDA Inspection
Stembanc IncStembanc Inc – FDA Inspection, Apr 27, 2010
Record Details
This FDA Inspection record concerns Stembanc Inc, with an inspection on April 27, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stembanc Inc
- Inspection Date
- April 27, 2010
- Product Type
- Biologics
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ID · 59b7f972-fe8b-4f6d-8966-0d61d4db73b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659051
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.80(d)(2)Plasma diluted test specimens
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.180(c)Availability of procedures
- 21 CFR 1271.80(c)Manufacturer instructions not followed
- 21 CFR 1271.160(b)(4)Training of personnel
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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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 12, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 4, 2013 | 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 862242 - 2014-02-12
- FDA Inspection 814359 - 2013-02-04
- FDA Inspection 596205 - 2009-08-31
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