483
Access Vascular, Inc.Access Vascular, Inc. – FDA 483, Oct 6, 2022
Record Details
An FDA inspection of Access Vascular, Inc. in Billerica, MA, revealed two significant observations. The firm failed to provide a documented statistical rationale for sampling plans for their Hydro MID Single Lumen Catheter and submitted Medical Device Reports (MDRs) for adverse events related to their Hydro-PICC Single Lumen Catheter beyond the required 30-day timeframe. These issues highlight deficiencies in quality system procedures and regulatory reporting compliance.
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ID · d1f98da1-d8c0-4b1a-a0e9-4ec7c116e1e2
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