FDA 483 - MICROspecialties, Inc. - February 18, 2025

An FDA inspection of MICROspecialties, LLC in Middletown, CT, revealed significant deficiencies in quality system controls for medical devices. The firm was cited for issues including fabricated sterilization certificates, unvalidated sterilization processes, inadequate finished device acceptance procedures, and poor documentation of corrective actions and device master records. These findings indicate a severe lack of control over critical manufacturing processes, potentially leading to the distribution of non-sterile products.