483
InfoRLife SAFDA 483 - InfoRLife SA - May 03, 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
InforLife SA, a sterile drug manufacturer in Campascio, Switzerland, received a Form 483 with two observations. The firm's quality control unit failed to approve or reject procedures, leading to the release of drug products with high impurity levels from packaging material. Additionally, the firm lacked adequate written procedures for production and process controls, resulting in visual inspection issues with air bubbles and cloudiness in drug products.
- Office
- Office of Partnerships
- Person
Open in Dashboard
ID · 74138f7e-af41-4c36-936a-247530642eeb