FDA 483 - SUMAR BIOTECH LLP - January 12, 2024

An FDA inspection of SUMAR BIOTECH LLP in Mehsana, Gujarat, India, conducted from January 9-12, 2024, revealed several significant deficiencies in their manufacturing and quality control operations for an intermediate product, as documented in a Form FDA 483. The inspection highlighted critical gaps in adherence to Good Manufacturing Practices (GMP).

Key violations included the failure to establish the accuracy, sensitivity, specificity, and reproducibility of essential test methods, such as HPLC and GC, before releasing product batches. Additionally, the stability program was found to be inadequate, lacking stability-indicating test methods and failing to include distributed batches in stability testing. Laboratory control mechanisms were severely deficient, with uncontrolled data management using Excel, an analyst's inability to explain calculations, unmanaged weigh slips, and the inappropriate assignment of administrator rights to Quality Control personnel on analytical software. Numerous HPLC errors were logged without documented review or corrective actions by the quality unit.

The firm also failed to adhere to quality control unit responsibilities, evident by the lack of written justifications for certain processes and the absence of change control for introducing new intermediate products. Furthermore, master production and control records were incomplete, relying on verbal instructions for critical operations, and equipment was utilized outside its qualified parameters.

SUMAR BIOTECH LLP must now implement comprehensive corrective and preventive actions to address these observations and ensure full compliance with regulatory requirements.