FDA 483 - Sumar Biotech LLP

SUMAR BIOTECH LLP, an intermediate manufacturer in Mehsana Sub-District, Gujarat, India, was cited for significant deficiencies across its quality control, laboratory operations, and production records. The inspection revealed a lack of established test methods, an inadequate stability program, poor laboratory control mechanisms including data integrity issues, and incomplete manufacturing documentation. These issues indicate a systemic failure to adhere to good manufacturing practices.