483
Televere Systems, LLCTelevere Systems, LLC – FDA 483, Apr 22, 2026
Record Details
An FDA inspection of Televere Systems, LLC in Janesville, WI, a manufacturer of software devices, revealed a significant deficiency in their quality system. The firm failed to adequately document processes for risk management related to their (b) (4) software device. This included a lack of a risk management procedure and a failure to conduct a risk assessment for potential hazards like unclear images or inaccurate measuring tools.
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