483
Martech Medical Products, MexicoFDA 483 - Martech Medical Products, Mexico - September 28, 2017
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 Martech Medical Products in Mexicali, Mexico, revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions and sterilization process control. These issues led to the release of unsterile product and a subsequent recall, indicating serious risks to product quality and patient safety.
Open in Dashboard
ID · a875df3d-dc5b-4566-9d3f-8222beb98a1f