FDA 483 - SUMAR BIOTECH LLP - January 12, 2024

An FDA inspection conducted at SUMAR BIOTECH LLP, an intermediate manufacturer located in Mehsana Sub-District, Gujarat, India, from January 9-12, 2024, revealed significant deficiencies in their manufacturing and quality control operations, indicating non-adherence to Good Manufacturing Practices. Key issues identified included a lack of established accuracy, sensitivity, specificity, and reproducibility for critical analytical test methods like HPLC and GC. The firm's stability program was found inadequate, failing to use stability-indicating methods or include distributed intermediate batches in stability testing. Deficient laboratory control mechanisms were noted, such as the use of uncontrolled Excel spreadsheets for calculations, inadequate documentation practices, inappropriate user access to analytical software, and unaddressed instrument errors. Furthermore, the quality control unit's responsibilities were not fully followed, with an absence of written justification for certain batch sizes, incomplete process validation, and a failure to initiate change control for new intermediates. Lastly, master production and control records lacked complete manufacturing instructions, with critical process parameters communicated verbally and equipment operated outside its qualified range. SUMAR BIOTECH LLP is required to address these observations by implementing comprehensive corrective and preventive actions and submitting them to the FDA.