Nantsound Inc
Form 483 issued February 23, 2022 · Park Ridge, Illinois
- Inspection
- Feb 16 – Feb 23, 2022
- Investigator
- Natasha R. Johnson
- Observations
- 1
- Pages
- 4
- FEI number
- 3011196525
In short: On February 23, 2022, FDA issued a Form 483 with 1 observation to Nantsound Inc in Park Ridge, Illinois (FEI 3011196525) after an inspection that ran Feb 16 – Feb 23, 2022. The investigator was Natasha R. Johnson. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for rework of nonconforming product have…
This inspection in context
Natasha R. Johnson
3 documents · 2019–2024
Cites 803.50(a)(2) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Illinois.
The firmNantsound Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nantsound Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Nantsound Inc?
Natasha R. Johnson is named on this Form 483, for the inspection of Feb 16 – Feb 23, 2022. Each investigator has a profile showing what they cite most.
When was Nantsound Inc inspected by FDA?
The inspection ran Feb 16 – Feb 23, 2022, and the Form 483 is dated February 23, 2022.
How do I get the full Form 483 for Nantsound 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.