483
Keystone IndustriesFDA 483 - Keystone Industries - November 07, 2025
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
Keystone Industries, a human drug manufacturer in Gibbstown, NJ, was cited for a significant deficiency in drug product component testing. The firm failed to perform required identity testing, including the USP limit test, on incoming high-risk components used in their over-the-counter drug products. This lapse raises concerns about the quality and safety of their manufactured drug products.
- Person
Open in Dashboard
ID · 48e137e1-74c9-46cc-bf44-164555606b70