483
Alltrista Plastics, LLCFDA 483 - Alltrista Plastics, LLC - March 04, 2020
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
An FDA inspection of Alltrista Plastics, LLC, a contract manufacturer in Reedsville, PA, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for finished device acceptance, supplier monitoring, and corrective and preventive actions. These issues indicate a lack of control over product release, supplier quality, and complaint resolution processes.
- Person
Open in Dashboard
ID · b277b0bd-29a8-4cb6-b249-37af43c22eda