FDA 483 - Access Vascular, Inc. - October 06, 2022

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.