Biomerieux IncAugust 20, 2019

FDA 483 - Biomerieux Inc - August 20, 2019

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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.

Company: Biomerieux Inc
Inspection Date: August 20, 2019
Product Type: Device
Office: Minneapolis District Office
People: Joseph D. Gong (issuing_officer)
Christina L. Bigham (Investigator )

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ID · 7225d3cb-a4ab-43a9-9fe4-845a7316aa89