FDA Inspection
New York Firefighters Skin Bank New York Presbyterian HospNew York Firefighters Skin Bank New York Presbyterian Hosp – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns New York Firefighters Skin Bank New York Presbyterian Hosp, with an inspection on April 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 19, 2018
- Product Type
- Biologics
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ID · e236e3dc-0097-4fc5-80a2-5f8abc2cb56b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048778
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New York Firefighters Skin Bank New York Presbyterian Hosp
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 15, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 23, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 9, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for New York Firefighters Skin Bank New York Presbyterian Hosp
- FDA Inspection 1225767 - 2023-12-19
- FDA Inspection 952441 - 2015-12-15
- FDA Inspection 898020 - 2014-09-23
- FDA Inspection 776705 - 2012-04-23
- FDA Inspection 589422 - 2009-06-09
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