483
Viva Pharmaceutical IncFDA 483 - Viva Pharmaceutical Inc - October 25, 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
An FDA inspection of Viva Pharmaceutical Inc. in Richmond, British Columbia, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included inadequate equipment cleaning, critical failures in the quality control unit's data integrity and oversight, and insufficient investigations into out-of-specification results. Additionally, the facility showed poor maintenance with damaged production room flooring.
Open in Dashboard
ID · 1045a00a-c3b3-4811-98aa-88f00296395e