FDA 483 - Veranova LP - February 15, 2023
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.
An FDA inspection of Veranova, L.P. in West Deptford, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately investigate customer complaints regarding inaccurate API documentation and implement effective corrective actions. Additionally, the inspection found that the company lacked sufficient written procedures for cleaning validation of non-dedicated manufacturing equipment, with a related CAPA remaining open for an extended period.
ID · 5c9511c0-1673-490a-9186-91cbf8b6d26a