FDA 483 - J. B. Chemicals and Pharmaceuticals Limited - February 07, 2020

An FDA inspection of Unique Pharmaceutical Laboratories, a human finished drug manufacturer in Bharuch, Gujarat, India, revealed significant deficiencies in their quality control unit. The firm failed to fully follow responsibilities and procedures, specifically regarding the accuracy of trend reports, the thoroughness of investigations, the detail in training records, and the definition of 'incidence' in their procedures. These issues indicate a lack of robust quality system oversight.