New York Blood Center, Inc.
Form 483 issued February 11, 2020 · Rye, New York
- Inspection
- Feb 4 – Feb 11, 2020
- Investigator
- Irina Gaberman
- Observations
- 4
- Pages
- 5
- FEI number
- 2473015
In short: On February 11, 2020, 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 Feb 4 – Feb 11, 2020. The investigator was Irina Gaberman. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Established test procedures and laboratory control…
- 04
Donors were not screened by a review of relevant medical records for risk factors of communicable…
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 211.160(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 laboratory controls, quality system and hCT/P. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 Feb 4 – Feb 11, 2020. Each investigator has a profile showing what they cite most.
When was New York Blood Center, Inc. inspected by FDA?
The inspection ran Feb 4 – Feb 11, 2020, and the Form 483 is dated February 11, 2020.
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.