483
Chamberlain Technologies LLCFDA 483 - Chamberlain Technologies LLC - May 09, 2025
Discuss this record with AI
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.
Record Details
An FDA inspection of Chamberlain Technologies LLC in Deer Park, IL, revealed that the firm failed to report a correction or removal of Class 2 medical devices to the FDA. The company incorrectly classified the action as a stock recovery, even though affected devices had been distributed and one was implanted in a patient, and its risk assessment for not reporting was inconsistent.
- Office
- Chicago District Office
- Person
Open in Dashboard
ID · af82db1e-7475-4f11-8787-831d37ac23fb