FDA Inspection
Wyckoff Heights Medical Center Blood BankWyckoff Heights Medical Center Blood Bank – FDA Inspection, Jan 10, 2014
Record Details
This FDA Inspection record concerns Wyckoff Heights Medical Center Blood Bank, with an inspection on January 10, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 10, 2014
- Product Type
- Biologics
View Company Profile
ID · ca1635bf-f9de-4006-aa33-e3356172aa72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 861530
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 600.14(a)(1)Who must report - receiving information
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 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 Wyckoff Heights Medical Center Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 22, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 15, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 3, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Wyckoff Heights Medical Center Blood Bank
- FDA Inspection 1074506 - 2018-11-29
- FDA Inspection 1006428 - 2017-03-22
- FDA Inspection 941829 - 2015-09-15
- FDA Inspection 790694 - 2012-07-03
- FDA Inspection 626058 - 2009-11-18
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.