FDA 483 - Dharma Research, Inc. - December 11, 2024

Dharma Research, Inc. in Miami, FL, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included a failure to document design validation results in the design history file and master batch records, discrepancies between device history records and master records regarding manufacturing conditions, and a lack of documented corrective and preventive actions for product complaints. These issues indicate a need for improved adherence to quality system regulations.