FDA EIR - Classic Wire Cut Co Inc - July 20, 2018

An FDA inspection of Classic Wire Cut Co Inc., a medical device contract manufacturer in Valencia, CA, was conducted from July 16-20, 2018. The inspection focused on the company's manufacturing of a biodegradable orthopedic implant fixation suture anchor system, and evaluated its Corrective and Preventive Action (CAPA) and Production and Process Controls systems. The inspection identified four primary areas of concern, resulting in a Form FDA-483. Violations included inadequate procedures for establishing and verifying corrective and preventive actions, insufficient controls for nonconforming products, and a lack of proper monitoring for critical cleaning process parameters. Additionally, the company's in-house calibration procedures lacked specific directions for accuracy and precision. These issues indicate deficiencies in adherence to the Quality System Regulation for medical devices. The CEO of Classic Wire Cut Co Inc. acknowledged the observations, committed to correcting them, and pledged to submit a detailed written response to the FDA within 15 business days.