FDA Inspection
CCRM DFWCCRM DFW – FDA Inspection, Jul 25, 2017
Record Details
This FDA Inspection record concerns CCRM DFW, with an inspection on July 25, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 39dacb04-0fa1-460b-8cd0-153ec6e618b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019066
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CCRM DFW
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 4, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 10, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 10, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CCRM DFW
- FDA Inspection 1282798 - 2025-09-04
- FDA Inspection 1114052 - 2019-12-04
- FDA Inspection 1023819 - 2017-07-25
- FDA Inspection 886734 - 2014-07-10
- FDA Inspection 886733 - 2014-07-10
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