Myerson LLC
Form 483 issued May 4, 2021 · Chicago, Illinois
- Inspection
- Mar 16 – May 4, 2021
- Investigator
- Shafiq S. Ahadi
- Observations
- 8
- Pages
- 6
- FEI number
- 3003928050
In short: On May 4, 2021, FDA issued a Form 483 with 8 observations to Myerson LLC in Chicago, Illinois (FEI 3003928050) after an inspection that ran Mar 16 – May 4, 2021. The investigator was Shafiq S. Ahadi. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
CAPA and design controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action have…
- 04
The device history record does not demonstrate that the device was manufactured in accordance with…
This inspection in context
Shafiq S. Ahadi
7 documents · 2016–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmMyerson LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Myerson LLC?
FDA listed 8 observations on this Form 483, mostly about cAPA, design controls and records & documents. 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?
Shafiq S. 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 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?
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.