Dharma Research, Inc. – FDA 483, Sep 30, 2022

Pharma Research, Inc. in Miami, FL, an OTC and prescription drug manufacturer, received a Form 483 with five observations highlighting significant deficiencies in their manufacturing and quality control processes. The inspection revealed issues including inadequate laboratory controls for water specifications, lack of process validation for drug products, and failure to test for objectionable microorganisms. Additionally, the firm's quality control unit did not follow procedures for deviations, change controls, and allowed the use of unreleased and expired materials, indicating a systemic breakdown in their quality system.