FDA Inspection
Texas Donor NetworkTexas Donor Network – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Texas Donor Network, with an inspection on December 14, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · e4c028f4-a7ef-44c2-9df0-01ee2695c733
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075469
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.60(c)(3)Statement of restrictions
Full citation text and observation details available on the Dashboard.
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.