FDA 483 - Escalon Medical Corp. - November 25, 2019

During an FDA inspection conducted from November 13 to November 25, 2019, medical device manufacturer Escalon Medical Corp. was cited for significant deficiencies in its quality system, indicating non-compliance with regulatory requirements. The observations primarily focused on inadequate controls across several critical areas.

Key violations included a systemic failure in establishing and following procedures for finished device acceptance, particularly concerning change management, process validation, and the release of products. The company implemented changes to packaging processes, equipment, and labeling software without proper validation, customer approval, or revalidation, and used unvalidated testing equipment. Production processes for medical devices, including packaging, lacked adequate development, control, and monitoring, leading to discrepancies in testing parameters and inconsistent seal integrity verification.

Environmental controls in the cleanroom were found deficient, with physical deterioration, inconsistent air sampling, and a lack of documented recovery procedures after power loss. Personnel practices were also cited for inadequate hygiene and gowning controls. Furthermore, the firm failed to properly document rework activities, lacked statistically valid sampling plans, and did not adequately evaluate critical suppliers and contractors. Repeated observations from a 2013 inspection highlighted ongoing issues in complaint handling, personnel training, corrective and preventive action procedures, and internal audit independence.

Escalon Medical Corp. is required to provide a comprehensive response to the FDA, detailing corrective and preventive actions to address these serious deviations and ensure full compliance with medical device quality system regulations.