FDA 483 - Acrostak (Schweiz) AG - June 15, 2023

Acrostak (Schweiz) AG received an FDA Form 483 following an inspection conducted from June 12-15, 2023, regarding its medical device manufacturing operations. The inspection highlighted several critical deficiencies in the company's quality system.

Key issues included inadequate procedures for controlling environmental conditions, specifically a lack of particle count monitoring during active manufacturing of M-CATH and M-CATH Flexy microcatheters. The company also demonstrated inadequate complaint handling processes, failing to properly evaluate complaints for reportability to the FDA under 21 CFR 803, such as a microcatheter tip breakage, and to ensure thorough investigations of reported device failures.

Furthermore, a critical manufacturing process for M-CATH microcatheters was not adequately validated, with worst-case parameters not properly documented or tested. Procedures for monitoring and documenting critical process parameters were also found to be insufficient. The risk analysis for microcatheters was deemed inadequate, particularly concerning the calculation of risks like embolism from catheter tip breakage and inconsistencies in probability assessments. Finally, the firm lacked adequate procedures for controlling nonconforming product, with instances of undocumented rework identified.

Acrostak (Schweiz) AG is responsible for addressing these observations and implementing comprehensive corrective and preventive actions to comply with FDA medical device quality system regulations.