483
Chamberlain Technologies LLCChamberlain Technologies LLC – FDA 483, May 9, 2025
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.
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- Chicago District Office
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ID · af82db1e-7475-4f11-8787-831d37ac23fb
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