FDA 483 - Apozeal Pharmaceuticals Inc. - October 15, 2025

During an inspection conducted from October 2 to October 15, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Apozeal Pharmaceuticals Inc., detailing significant observations regarding their manufacturing practices. These observations indicate a failure to adhere to current Good Manufacturing Practices (cGMP) for drug products.

Key issues included a systemic failure to thoroughly investigate unexplained discrepancies, such as undocumented serialization incidents and a persistently leaking bottle filler that soiled drug product containers without formal investigation. Furthermore, drug products were reportedly produced and distributed after being manufactured and filled outside their specified temperature ranges without proper risk assessment.

The inspection also highlighted deficiencies in the Quality Control Unit, specifically regarding the failure to investigate microbial water contamination exceeding action limits and inadequate document controls, where batch records and quality registers were not securely managed. Laboratory controls lacked appropriate alert levels for water system microbial trends, impacting proactive quality measures.

Critical shortcomings in equipment cleaning and maintenance procedures were noted, with no completed cleaning validation studies for shared manufacturing equipment. The firm also failed to conduct swab recovery studies or consistently perform microbial analysis post-cleaning, despite previous microbial contamination failures. Finally, a lack of documented Quality Assurance review for electronic audit trails on laboratory instrument software raised concerns about data integrity.

Apozeal Pharmaceuticals Inc. is required to provide a comprehensive response addressing each observation with detailed corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality.