New York Blood Center, Inc.
Form 483 issued September 29, 2017 · Rye, New York
- Inspection
- Sep 6 – Sep 29, 2017
- Investigator
- Irina Gaberman
- Observations
- 4
- Pages
- 5
- FEI number
- 2473015
In short: On September 29, 2017, FDA issued a Form 483 with 4 observations to New York Blood Center, Inc. in Rye, New York (FEI 2473015) after an inspection that ran Sep 6 – Sep 29, 2017. The investigator was Irina Gaberman. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).
At a glance
4 of 4 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Written standard operating procedures including all steps to be followed in the processing, storage and distribution…
- 0221 CFR 600.15
Failure to maintain temperatures during shipment of Red Blood Cells…
- 03
Failure to maintain quality…
- 04
Records are not concurrently maintained with the performance of each significant step in the processing of…
This inspection in context
Irina Gaberman
8 documents · 2011–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmNew York Blood Center, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New York Blood Center, Inc.?
FDA listed 4 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.
Who inspected New York Blood Center, Inc.?
Irina Gaberman is named on this Form 483, for the inspection of Sep 6 – Sep 29, 2017. Each investigator has a profile showing what they cite most.
When was New York Blood Center, Inc. inspected by FDA?
The inspection ran Sep 6 – Sep 29, 2017, and the Form 483 is dated September 29, 2017.
How do I get the full Form 483 for New York Blood Center, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.