Illuminoss Medical Inc
Form 483 issued November 2, 2022 · East Providence, Rhode Island
- Inspection
- Oct 4 – Nov 2, 2022
- Investigator
- Maryam Tabatabaie
- Observations
- 6
- Pages
- 6
- FEI number
- 3006845464
In short: On November 2, 2022, FDA issued a Form 483 with 6 observations to Illuminoss Medical Inc in East Providence, Rhode Island (FEI 3006845464) after an inspection that ran Oct 4 – Nov 2, 2022. The investigator was Maryam Tabatabaie. Most observations concern cAPA and production & process controls.
At a glance
4 of 6 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Procedures for corrective and preventive action have…
- 04
Procedures for design change have…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmIlluminoss Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Illuminoss Medical Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Illuminoss Medical Inc?
Maryam Tabatabaie is named on this Form 483, for the inspection of Oct 4 – Nov 2, 2022. Each investigator has a profile showing what they cite most.
When was Illuminoss Medical Inc inspected by FDA?
The inspection ran Oct 4 – Nov 2, 2022, and the Form 483 is dated November 2, 2022.
How do I get the full Form 483 for Illuminoss Medical 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.