FDA Inspection
RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank)RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank) – FDA Inspection, Nov 8, 2010
Record Details
This FDA Inspection record concerns RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank), with an inspection on November 8, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 8, 2010
- Product Type
- Biologics
View Company Profile
ID · db0c87b7-b8f2-4888-92ae-19628ef9c18c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697059
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 606.100(b)(10)Controlling storage temperatures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank)
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 26, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 28, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for RWJ Barnabas Health/Trinitas Regional Medical Center (Blood Bank)
- FDA Inspection 1257009 - 2024-12-12
- FDA Inspection 1187435 - 2022-10-26
- FDA Inspection 1076865 - 2018-12-19
- FDA Inspection 992584 - 2016-11-08
- FDA Inspection 894580 - 2014-08-28
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.