FDA EIR - Value Plastics, Inc. dba Nordson Medical - January 05, 2018

A routine FDA inspection of Value Plastics, Inc., doing business as Nordson Medical, was conducted from January 3-5, 2018, at its Loveland, CO facility. The inspection, carried out under the regulatory framework for medical device manufacturers, focused on the company's Corrective & Preventive Action and Production & Process Controls subsystems. The inspection revealed two primary deficiencies, documented on an FDA-483 form. Firstly, the company did not adequately validate processes for its automated assembly machines, which are critical for manufacturing Class II stopcocks. Issues included a lack of complete data for critical acceptance criteria, absence of proper installation and operational qualification protocols, and performance qualifications not conducted under representative production conditions. Secondly, Value Plastics had not established comprehensive preventative maintenance schedules for essential manufacturing equipment, specifically for a key Automated Assembly Machine used in stopcock assembly. Raymond L. Townsend, the Plant Manager, accepted these observations without dispute and committed to addressing all identified issues. A formal written response outlining corrective actions was promised within 15 business days. The FDA noted it would follow up on the improvements to the preventative maintenance program during the next inspection.