Beckman Coulter, Inc
Form 483 issued March 11, 2015 · West Sacramento, California
- Inspection
- Feb 23 – Mar 11, 2015
- Investigator
- Binh T. Nguyen
- Observations
- 1
- Pages
- 2
- FEI number
- 2919016
In short: On March 11, 2015, FDA issued a Form 483 with 1 observation to Beckman Coulter, Inc in West Sacramento, California (FEI 2919016) after an inspection that ran Feb 23 – Mar 11, 2015. The investigator was Binh T. Nguyen. Most observations concern cAPA; the most-cited regulation is 21 CFR 806.10 (reports of corrections and removals).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 806.10(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmBeckman Coulter, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Beckman Coulter, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 806.10 (reports of corrections and removals). The opening words of each observation are shown on this page.
Who inspected Beckman Coulter, Inc?
Binh T. Nguyen is named on this Form 483, for the inspection of Feb 23 – Mar 11, 2015. Each investigator has a profile showing what they cite most.
When was Beckman Coulter, Inc inspected by FDA?
The inspection ran Feb 23 – Mar 11, 2015, and the Form 483 is dated March 11, 2015.
How do I get the full Form 483 for Beckman Coulter, 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.