FDA Inspection
New York Blood Center EnterprisesNew York Blood Center Enterprises – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on October 27, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · bf5af96f-3484-4e64-952c-8066735ef393
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221222
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer's instructions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New York Blood Center Enterprises
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2026 | Not classified | New York District Office | Blood and Blood Products |
| February 25, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 22, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 29, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York Blood Center Enterprises
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.