Biodex Medical Systems, Inc
Form 483 issued March 18, 2015 · Shirley, New York
- Inspection
- Mar 12 – Mar 18, 2015
- Investigator
- Kwong P. Lee
- Observations
- 5
- Pages
- 3
- FEI number
- 2431314
In short: On March 18, 2015, FDA issued a Form 483 with 5 observations to Biodex Medical Systems, Inc in Shirley, New York (FEI 2431314) after an inspection that ran Mar 12 – Mar 18, 2015. The investigator was Kwong P. Lee. Most observations concern production & process controls and records & documents.
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A device history record…
- 02
Procedures for identifying with a control number each unit, lot, or batch of implantable or life…
- 03
Process validation results have…
- 04
Production processes were not controlled to ensure that a device…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmBiodex Medical Systems, 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 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biodex Medical Systems, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Biodex Medical Systems, Inc?
Kwong P. Lee is named on this Form 483, for the inspection of Mar 12 – Mar 18, 2015. Each investigator has a profile showing what they cite most.
When was Biodex Medical Systems, Inc inspected by FDA?
The inspection ran Mar 12 – Mar 18, 2015, and the Form 483 is dated March 18, 2015.
How do I get the full Form 483 for Biodex Medical Systems, 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.