FDA 483 - Concord Biotech Limited - May 02, 2025

During an inspection conducted from April 28, 2025, to May 2, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Concord Biotech Limited, an Active Pharmaceutical Ingredient (API) manufacturer located in Dbolka Ahmedabad, Gujarat, India. The inspection revealed significant concerns regarding the firm"s adherence to manufacturing quality standards, implying non-compliance with Current Good Manufacturing Practices (CGMP). A primary observation highlighted the failure to adequately clean equipment and utensils. Inspectors noted visible residues on agitators and internal walls, as well as particles on the bottom of equipment used in API production, despite logbook entries indicating prior cleaning. This directly impacts the prevention of contamination and carry-over, which could compromise the quality of intermediate products and APIs. Additionally, the FDA found deficiencies in the company’s laboratory controls. Specifically, the firm"s test procedures were deemed not to be scientifically sound or appropriate to consistently assure that drug products meet established standards for identity, strength, quality, and purity. These observations necessitate prompt corrective actions from Concord Biotech Limited to address the identified issues, ensure product quality, and maintain regulatory compliance.