Myerson LLC 5106 NR
Form 483 issued May 4, 2021 · Chicago, Illinois
- Inspection
- Mar 16 – May 4, 2021
- Investigator
- Shafig Ahadi
- Observations
- 1
- Pages
- 6
In short: On May 4, 2021, FDA issued a Form 483 with 1 observation to Myerson LLC 5106 NR in Chicago, Illinois after an inspection that ran Mar 16 – May 4, 2021. The investigator was Shafig Ahadi. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted withm 30 days of receiving or otherwise becoming aware of…
This inspection in context
Shafig Ahadi
6 documents · 2021–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmMyerson LLC 5106 NR history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Myerson LLC 5106 NR?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Myerson LLC 5106 NR?
Shafig Ahadi is named on this Form 483, for the inspection of Mar 16 – May 4, 2021. Each investigator has a profile showing what they cite most.
When was Myerson LLC 5106 NR inspected by FDA?
The inspection ran Mar 16 – May 4, 2021, and the Form 483 is dated May 4, 2021.
How do I get the full Form 483 for Myerson LLC 5106 NR?
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.