FDA 483 - Omega Plastics Inc. - July 16, 2018

Omega Plastics, Inc. in Clinton Township, MI, received a Form FDA 483 with six observations related to significant deficiencies in their quality system for medical device manufacturing. The inspection revealed issues with process validation, process controls, environmental controls in cleanrooms, corrective and preventive actions, quality audits, and control of nonconforming product. These findings indicate a need for comprehensive improvements across multiple critical manufacturing and quality assurance areas.