InfuTronix LLC
Form 483 issued February 15, 2022 · Natick, Massachusetts
- Inspection
- Jan 19 – Feb 15, 2022
- Investigator
- Sara M. Onyango
- Observations
- 5
- Pages
- 6
- FEI number
- 3011581906
In short: On February 15, 2022, FDA issued a Form 483 with 5 observations to InfuTronix LLC in Natick, Massachusetts (FEI 3011581906) after an inspection that ran Jan 19 – Feb 15, 2022. The investigator was Sara M. Onyango. Most observations concern cAPA and design controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Design validation did not ensure the device conforms to defined user…
- 04
The evaluation of potential…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmInfuTronix LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InfuTronix LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected InfuTronix LLC?
Sara M. Onyango is named on this Form 483, for the inspection of Jan 19 – Feb 15, 2022. Each investigator has a profile showing what they cite most.
When was InfuTronix LLC inspected by FDA?
The inspection ran Jan 19 – Feb 15, 2022, and the Form 483 is dated February 15, 2022.
How do I get the full Form 483 for InfuTronix LLC?
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.