483
Thoracent, LLCThoracent, LLC – FDA 483, Dec 11, 2025
Record Details
An FDA inspection of Thoracent, LLC in Huntington, NY, identified significant deficiencies in their quality system. The firm failed to establish written procedures for Medical Device Reporting (MDRs), complaint handling, and corrective and preventive actions. These observations indicate a lack of fundamental controls for managing product quality and safety.
View Company Profile
ID · 31b602e8-4e0b-421d-91af-556ebbbcdc75
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.