FDA 483 - Abbott Vascular - November 16, 2023

An FDA inspection of Abbott Vascular's manufacturing facility in Clonmel, Co. Tipperary, Ireland, conducted from November 13-16, 2023, revealed significant observations regarding their BHT (Butylated Hydroxytoluene) Content test method for stents. The main issues centered on inadequate validation and transfer protocols for this critical test. Specifically, the agency noted that the test method validation did not sufficiently demonstrate repeatability and reproducibility, particularly concerning the number of samples analyzed. A change order permitting a reduction in the Gas Chromatography Mass Spectrometry (GCMS) sample size was found to be insufficiently justified, relying on the ongoing process rather than robust validation data. Additionally, the transfer of this BHT Content test method to the site lacked clear documentation to prove method reproducibility when processing different sample quantities. These observations indicate potential non-compliance with FDA quality system requirements for medical device manufacturers. Abbott Vascular is responsible for addressing these findings, conducting internal audits, and implementing corrective actions to ensure compliance and maintain the quality and reliability of their products.