FDA 483 - Farnam Companies - September 19, 2025

During an inspection conducted from September 15 to September 19, 2025, the Food and Drug Administration identified significant deficiencies at a pharmaceutical manufacturing facility. The inspection revealed multiple violations of Good Manufacturing Practices, highlighting a lack of robust quality control and operational oversight.

Key issues included a failure to adequately validate the complete production process for drug products, especially after equipment changes, and the absence of defined bulk hold times. The firm also did not perform required stability studies for drug products, with only one batch tested since operations began in 2019. Furthermore, there was a systemic failure to ensure the reliability of component suppliers, as critical raw materials were not routinely tested for identification, and supplier qualifications were lacking.

The Quality Control Unit demonstrated significant shortcomings, including uncontrolled storage of pre-printed labels, incomplete documentation of batch record reviews prior to product release, and inadequate storage conditions for finished drug products that did not maintain label specifications. Investigations into non-conformances were found to be insufficient, lacking thorough root cause analysis and verification of corrective actions. Additionally, the firm lacked detailed written procedures and adequate documentation for equipment cleaning and maintenance.

These observations indicate a need for comprehensive corrective actions across production, quality assurance, and laboratory controls to ensure drug product identity, strength, purity, and quality in compliance with federal regulations.