FDA 483 - Molecular PharmaGroup - August 11, 2025

Molecular PharmaGroup LLC underwent an FDA inspection from July 28 to August 11, 2025, which identified significant deficiencies in its sterile drug manufacturing operations, as documented in an FDA Form 483. The observed issues indicate potential non-compliance with current Good Manufacturing Practices (cGMP).

Key violations included inadequate control over aseptic processing areas, specifically the lack of a differential pressure gauge for an ISO 5 vertical laminar airflow hood used for sterile filling. Procedures designed to prevent microbiological contamination were also deficient; airflow visualization studies did not simulate critical interventions, and the environmental and personnel monitoring program was insufficient, including inadequate air sampling during critical operations and the use of inappropriate goggles by operators. Furthermore, sterilization equipment qualification was found lacking, with biological indicators used having an insufficient starting population and no verification of their identity or population.

Lastly, the company failed to establish written procedures for and conduct Annual Product Reviews for numerous batches of Ethanol 70% Injection, which are essential for evaluating product quality. Molecular PharmaGroup LLC is expected to implement prompt corrective actions to address these observations and ensure regulatory compliance.