FDA 483 - Dynasthetics LLC - January 11, 2024

Dynasthetics LLC, a medical device manufacturer in Salt Lake City, UT, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of process validation for critical product testing, inadequate adherence to in-process product acceptance procedures, and failures in documenting and completing corrective and preventive actions. These issues indicate a need for improved quality control and procedural compliance.