Banyan USA LLC
Form 483 issued September 12, 2023 · Hauppauge, New York
- Inspection
- Sep 5 – Sep 12, 2023
- Investigator
- Andrew Garufi
- Observations
- 9
- Pages
- 6
- FEI number
- 3020737798
In short: On September 12, 2023, FDA issued a Form 483 with 9 observations to Banyan USA LLC in Hauppauge, New York (FEI 3020737798) after an inspection that ran Sep 5 – Sep 12, 2023. The investigator was Andrew Garufi. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities have…
- 02
Acceptance or rejection of incoming…
- 03
The evaluation of potential…
- 04
Schedules for the adjustment, cleaning, and other maintenance of equipment…
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 firmBanyan USA LLC 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 Banyan USA LLC?
FDA listed 9 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Banyan USA LLC?
Andrew Garufi is named on this Form 483, for the inspection of Sep 5 – Sep 12, 2023. Each investigator has a profile showing what they cite most.
When was Banyan USA LLC inspected by FDA?
The inspection ran Sep 5 – Sep 12, 2023, and the Form 483 is dated September 12, 2023.
How do I get the full Form 483 for Banyan USA 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.