483
Biomerieux IncBiomerieux Inc – FDA 483, Aug 20, 2019
Record Details
Biomerieux Inc. in Hazelwood, MO, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in the firm's post-market risk analysis process, which failed to adequately incorporate post-market data. Additionally, the firm was cited for failing to submit Medical Device Reports (MDRs) within the required 30-day timeframe for device malfunctions.
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ID · 7225d3cb-a4ab-43a9-9fe4-845a7316aa89
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