483
Metropolis International LLCFDA 483 - Metropolis International LLC - January 27, 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.
Record Details
Metropolis International LLC, a medical device refurbisher in Long Island City, NY, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in its quality system, specifically regarding the lack of established procedures and adequate documentation for complaint handling, corrective and preventive actions (CAPA), and process controls for refurbished devices.
Open in Dashboard
ID · cc27b944-106e-43fd-8912-56cbbd89aaf4