483
Martech Medical Products, MexicoFDA 483 - Martech Medical Products, Mexico - September 28, 2017
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.
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ID · a875df3d-dc5b-4566-9d3f-8222beb98a1f