FDA 483 - Biomerieux Inc - August 20, 2019

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.