FDA Inspection
Stembanc IncStembanc Inc – FDA Inspection, Feb 4, 2013
Record Details
This FDA Inspection record concerns Stembanc Inc, with an inspection on February 4, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stembanc Inc
- Inspection Date
- February 4, 2013
- Product Type
- Biologics
View Company Profile
ID · 1c138f34-1dd3-4c20-920b-483c97e6c875
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814359
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.80(a)Birth mother sample not tested
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.250(c)All labeling requirements met
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
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 12, 2014 | 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 862242 - 2014-02-12
- FDA Inspection 659051 - 2010-04-27
- FDA Inspection 596205 - 2009-08-31
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.