InfuTronix LLC
Amended 483 issued August 16, 2023 · Natick, Massachusetts
- Inspection
- Jun 21 – Aug 16, 2023
- Investigator
- Nabil Nakhoul
- Observations
- 4
- Pages
- 4
- FEI number
- 3011581906
In short: On August 16, 2023, FDA issued a Amended 483 with 4 observations to InfuTronix LLC in Natick, Massachusetts (FEI 3011581906) after an inspection that ran Jun 21 – Aug 16, 2023. The investigator was Nabil Nakhoul. Most observations concern cAPA and management controls.
At a glance
3 of 4 observations on this amended 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Nabil Nakhoul
4 documents · 2023–2026
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) 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 documentsOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at InfuTronix LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected InfuTronix LLC?
Nabil Nakhoul is named on this Amended 483, for the inspection of Jun 21 – Aug 16, 2023. Each investigator has a profile showing what they cite most.
When was InfuTronix LLC inspected by FDA?
The inspection ran Jun 21 – Aug 16, 2023, and the Amended 483 is dated August 16, 2023.
How do I get the full Amended 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.