Biodex Medical Systems, Inc
Form 483 issued February 10, 2023 · Shirley, New York
- Inspection
- Jan 25 – Feb 10, 2023
- Investigator
- Kwong P. Lee
- Observations
- 2
- Pages
- 2
- FEI number
- 2431314
In short: On February 10, 2023, FDA issued a Form 483 with 2 observations to Biodex Medical Systems, Inc in Shirley, New York (FEI 2431314) after an inspection that ran Jan 25 – Feb 10, 2023. The investigator was Kwong P. Lee. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
2 of 2 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.184 (1×) · 820.40(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device history record has…
- 02
Records of changes to documents…
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 2 observations on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.184 (device history record). 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 Jan 25 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Biodex Medical Systems, Inc inspected by FDA?
The inspection ran Jan 25 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
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.