FDA 483 - R.L. Fine Chem Private Limited

An FDA inspection of RL Fine Chem Pvt. Ltd. in Bangalore, India, a non-sterile API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate facility design and maintenance leading to potential contamination, improper storage conditions for materials and finished goods, and failures in investigation procedures for batch deviations and complaints. Additionally, the firm's quality control unit did not fully adhere to its own training and CAPA procedures.