FDA 483 - Patrin Pharma, Inc. - May 06, 2019

Patlin Pharma Inc. in Niles, IL, a specification developer and distributor of the H-Chlor 12, Class 2 jet lavage device, was cited for multiple deficiencies in its quality system during an FDA inspection. The observations primarily concern the lack of established procedures for supplier evaluation, complaint handling, corrective and preventive actions, quality audits, and device history records. These issues indicate a fundamental lack of a robust quality management system.