International Hospital Products, Inc. – FDA 483, Mar 19, 2019

An FDA inspection of International Hospital Products, Inc. in Littleton, CO, a medical device manufacturer of Baker Jejunostomy Tubes, revealed 11 significant quality system deficiencies. The firm failed to establish and maintain adequate procedures for critical processes such as process validation, finished device acceptance, purchasing controls, device history and master records, design changes, complaint handling, nonconforming product control, and quality audits. These observations indicate a comprehensive breakdown in the firm's quality management system.