483
Janssen Ortho LLCJanssen Ortho LLC – FDA 483, Jun 13, 2011
Record Details
Janssen Ortho L.L.C. in Gurabo, PR, a drug manufacturer, was cited for deficiencies in its quality system. The firm failed to adequately investigate a product recall for Topomax due to TBA contamination, not extending the assessment to all potentially affected batches. Additionally, laboratory controls for evaluating drug products for contaminants were found to be insufficient.
View Company Profile
ID · 9f01de45-456f-4580-a094-c4044333d924
Other documents for Janssen Ortho LLC
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.