483
Commercial Plastics Kenosha LLCFDA 483 - Commercial Plastics Kenosha LLC - November 07, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 15eb0869-ad57-4ec0-ad6d-531af373cbc6