FDA 483 - Polyconversions, Inc. - August 07, 2019

An FDA inspection of Polyconversions, Inc. in Champaign, IL, revealed significant deficiencies in the firm's quality system for manufacturing PolyWear Embossed Gowns. The inspection cited failures to establish and maintain critical procedures for medical device reporting, corrective and preventive actions, process validation, incoming product acceptance, complaint handling, and supplier quality. These issues indicate a lack of adequate controls to ensure device safety and quality.