FDA 483 - Aarkish Pharmaceuticals NJ Inc - October 24, 2025

During an inspection conducted from October 20 to October 24, 2025, the FDA issued a Form 483 to an unnamed firm, citing two significant observations related to quality control and equipment management. These observations indicate potential deviations from regulatory expectations, requiring the firm to implement corrective actions.The first observation detailed deficiencies within the quality control unit's responsibilities and procedures. Specifically, the firm's written procedures, including SOP RQC-014-02, were found to be inadequate as they failed to establish a comprehensive system audit trail review program. This program is critical for ensuring the complete and accurate historical data generated by laboratory systems, as current data review processes do not fully evaluate system-wide audit trails for conformance to test parameters and data controls.The second observation concerned the design and qualification of equipment used in drug product manufacturing, processing, packing, or holding. The inspection found that the equipment qualification for stability chambers was insufficient, failing to address how power would be maintained for the equipment and temperature/humidity sensors during power outages. Additionally, SOP #RQA-016-01, governing the stability study program, lacked detailed instructions on evaluating the time variation of cumulative hours for these critical studies. The firm is expected to respond to these observations by outlining its plan to correct the identified deficiencies and ensure compliance with the Federal Food, Drug, and Cosmetic Act.