FDA Inspection
Blood Bank of Delmarva, A Division of New York Blood Center, Inc.Blood Bank of Delmarva, A Division of New York Blood Center, Inc. – FDA Inspection, Nov 12, 2019
Record Details
This FDA Inspection record concerns Blood Bank of Delmarva, A Division of New York Blood Center, Inc., with an inspection on November 12, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 12, 2019
- Product Type
- Biologics
View Company Profile
ID · 4eeaf187-991a-4009-98f9-cce515288d0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109451
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.192Quality control unit review of records
- 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 Blood Bank of Delmarva, A Division of New York Blood Center, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 15, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Blood Bank of Delmarva, A Division of New York Blood Center, Inc.
- FDA Inspection 1025392 - 2017-08-28
- FDA Inspection 932165 - 2015-06-15
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.