WS Audiology USA Inc.
Form 483 issued October 20, 2025 · Hauppauge, New York
- Inspection
- Oct 15 – Oct 20, 2025
- Investigator
- Andrew Garufi
- Observations
- 1
- Pages
- 3
- FEI number
- 2430101
In short: On October 20, 2025, FDA issued a Form 483 with 1 observation to WS Audiology USA Inc. in Hauppauge, New York (FEI 2430101) after an inspection that ran Oct 15 – Oct 20, 2025. The investigator was Andrew Garufi. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in New York.
The firmWS Audiology USA Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WS Audiology USA Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected WS Audiology USA Inc.?
Andrew Garufi is named on this Form 483, for the inspection of Oct 15 – Oct 20, 2025. Each investigator has a profile showing what they cite most.
When was WS Audiology USA Inc. inspected by FDA?
The inspection ran Oct 15 – Oct 20, 2025, and the Form 483 is dated October 20, 2025.
How do I get the full Form 483 for WS Audiology USA 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.