FDA Inspection
Harborview Medical CenterHarborview Medical Center – FDA Inspection, Jul 8, 2011
Record Details
This FDA Inspection record concerns Harborview Medical Center, with an inspection on July 8, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Harborview Medical Center
- Inspection Date
- July 8, 2011
- Product Type
- Biologics
View Company Profile
ID · b5e6283a-42b5-40cd-a19b-ee02438c9ef5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734391
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.270(d)Retention time (10 year rules)
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Harborview Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2024 | Not classified | Seattle District Office | |
| March 28, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 14, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 8, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Harborview Medical Center
- FDA Inspection 1256057 - 2024-10-28
- FDA Inspection 1167127 - 2022-03-28
- FDA Inspection 1024415 - 2017-08-14
- FDA Inspection 900844 - 2014-10-23
- FDA Inspection 874438 - 2014-04-08
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.