Beckman Coulter, Inc.
Form 483 issued October 16, 2017 · Miami, Florida
- Inspection
- Jul 25 – Oct 16, 2017
- Investigator
- Dianiris C. Ayala
- Observations
- 4
- Pages
- 7
- FEI number
- 3000203293
In short: On October 16, 2017, FDA issued a Form 483 with 4 observations to Beckman Coulter, Inc. in Miami, Florida (FEI 3000203293) after an inspection that ran Jul 25 – Oct 16, 2017. The investigator was Dianiris C. Ayala. Most observations concern cAPA and production & process controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
Written MDR procedures have not been implemented. Failure to implement procedure Event and Incident Reporting for…
- 04
Procedures for corrective and preventive action have not been adequately established. Your firm’s procedures, Corrective and…
This inspection in context
Dianiris C. Ayala
8 documents · 2009–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmBeckman Coulter, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.200(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Beckman Coulter, Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Beckman Coulter, Inc.?
Dianiris C. Ayala is named on this Form 483, for the inspection of Jul 25 – Oct 16, 2017. Each investigator has a profile showing what they cite most.
When was Beckman Coulter, Inc. inspected by FDA?
The inspection ran Jul 25 – Oct 16, 2017, and the Form 483 is dated October 16, 2017.
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.