FDA Inspection
Stembanc IncStembanc Inc – FDA Inspection, Aug 31, 2009
Record Details
This FDA Inspection record concerns Stembanc Inc, with an inspection on August 31, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stembanc Inc
- Inspection Date
- August 31, 2009
- Product Type
- Biologics
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ID · 9b31a0a8-3cb3-44f7-9be2-7760ef9083e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596205
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.80(a)Birth mother sample not tested
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.50(a)Responsible person to determine, document
- 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 |
| April 27, 2010 | 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 659051 - 2010-04-27
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