New York Blood Center, Inc.
Form 483 issued November 22, 2017 · Rye, New York
- Observations
- 4
- Pages
- 4
- FEI number
- 2473015
In short: On November 22, 2017, FDA issued a Form 483 with 4 observations to New York Blood Center, Inc. in Rye, New York (FEI 2473015). Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
4 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is lack of assurance that Corrective and Preventive actions were implemented and verified for effectiveness…
- 02
Observation 2: scanned text, readable in the full document.
- 03
There is no documentation to support that Operati nnel, who have the roles and responsibilities for…
- 04
Notall changes to storage and laboratories are initiated and/or reviewed and approved…
This inspection in context
Questions about this 483
What did FDA find at New York Blood Center, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was New York Blood Center, Inc. inspected by FDA?
This Form 483 is dated November 22, 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.