FDA 483 - Humco Holding Group, Inc. - March 13, 2020

The FDA conducted an inspection of Humco Holding Group, Inc., a drug manufacturer and repackager located in Texarkana, TX, from February 24 to March 13, 2020. The inspection revealed several significant compliance issues related to the company's quality systems and production processes.

Key violations included the failure to thoroughly investigate unexplained discrepancies or out-of-specification (OOS) results in drug batches. For example, stability lots of Estriol 10% Concentrate failed to meet specifications, yet no comprehensive investigation was conducted. Similarly, multiple OOS results for microbial testing were noted, with the organism Aspergillus terreus repeatedly identified, but investigations did not adequately address the root cause or potential impacts on other batches.

Additionally, the firm lacked written procedures for production and process controls to ensure drug products meet their purported identity, strength, quality, and purity. Specific issues included inadequate investigation and corrective actions for OOS results related to Benzocaine and insufficient documentation for packaging processes of new drug products.

The FDA's observations highlight the need for Humco Holding Group to implement corrective actions, including thorough investigations of OOS results, comprehensive root cause analyses, and the establishment of robust production and process control procedures. The company must address these deficiencies to ensure compliance with regulatory standards and maintain product quality and safety.