FDA 483 - Commercial Plastics Kenosha LLC - November 07, 2024

Commercial Plastics Kenosha LLC, a medical device contract manufacturer in Kenosha, WI, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate documentation of process validation, insufficient procedures for nonconforming product control and rework, and unvalidated software. Additionally, the firm lacked established procedures for training and finished device acceptance.