Thoracent, LLC
Form 483 issued December 11, 2025 · Huntington, New York
- Inspection
- Dec 10 – Dec 11, 2025
- Investigator
- Preston M. Lee
- Observations
- 3
- Pages
- 4
- FEI number
- 3013337852
In short: On December 11, 2025, FDA issued a Form 483 with 3 observations to Thoracent, LLC in Huntington, New York (FEI 3013337852) after an inspection that ran Dec 10 – Dec 11, 2025. The investigator was Preston M. Lee. Most observations concern cAPA.
At a glance
3 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action…
This inspection in context
Preston M. Lee
1 document · 2025
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New York.
The firmThoracent, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thoracent, LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected Thoracent, LLC?
Preston M. Lee is named on this Form 483, for the inspection of Dec 10 – Dec 11, 2025. Each investigator has a profile showing what they cite most.
When was Thoracent, LLC inspected by FDA?
The inspection ran Dec 10 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.
How do I get the full Form 483 for Thoracent, 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.