FDA Inspection
Edward Hospital Blood BankEdward Hospital Blood Bank – FDA Inspection, Oct 7, 2010
Record Details
This FDA Inspection record concerns Edward Hospital Blood Bank, with an inspection on October 7, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Edward Hospital Blood Bank
- Inspection Date
- October 7, 2010
- Product Type
- Biologics
View Company Profile
ID · cbc61b47-ce49-477f-b290-e4accc2c8ace
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 694554
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 610.47Notification of transfusion recipients
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Edward Hospital Blood Bank
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Edward Hospital Blood Bank
- FDA Inspection 787489 - 2012-06-21
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.