FDA 483 - Dharma Research, Inc. - March 18, 2019

Dhama Research, Inc., a medical device manufacturer in Miami, FL, received a Form FDA-483 with 12 observations following an inspection. The findings indicate significant and systemic deficiencies across its quality system, including inadequate process validation, design controls, document control, and risk analysis. Several of these issues were noted as repeated observations from a previous inspection in September 2014, highlighting a persistent lack of compliance with regulatory requirements.