FDA Inspection
St. Thomas More Hospital Blood BankSt. Thomas More Hospital Blood Bank – FDA Inspection, Jun 30, 2010
Record Details
This FDA Inspection record concerns St. Thomas More Hospital Blood Bank, with an inspection on June 30, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 30, 2010
- Product Type
- Biologics
View Company Profile
ID · 198d175c-bd49-47ab-874a-ed8d4020dfed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669382
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 640.3(f)Donations in less than eight weeks
- 21 CFR 640.3(d)Therapeutic bleedings
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 610.41Donor Deferral
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.160(b)Required records
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 606.171Biological product deviation report
- 21 CFR 610.41Donor Deferral - reentry
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St. Thomas More Hospital Blood Bank
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for St. Thomas More Hospital Blood Bank
- FDA Inspection 745809 - 2011-09-14
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.