Onkos Surgical, Inc. – FDA 483, Oct 26, 2023

This FDA Form 483 outlines critical observations made during an inspection of a pharmaceutical manufacturing facility, highlighting significant non-compliance with Good Manufacturing Practices (GMP). The inspection revealed that the company's quality control unit lacked the necessary authority to adequately review production records and ensure comprehensive investigations into batch failures, as demonstrated by unapproved deviation investigations for rejected batches. Production and process control procedures were also found to be deficient, with operators observed deviating from master batch record instructions for mixing times without proper documentation or initiation of deviations. Furthermore, numerous batch production records were incomplete, missing essential details such as signatures, dates, and documentation of in-process checks. These issues collectively indicate that the methods employed in the manufacture, processing, packing, and holding of drug products do not conform to current GMP, leading to adulterated products under regulatory framework. The company is expected to address these observations by engaging with the FDA or submitting a comprehensive plan for corrective actions to achieve regulatory compliance.