Houston Rx LLC – FDA 483, Aug 28, 2026

From August 20 to August 28, 2026, the FDA inspected Houston Rx LLC, a producer of sterile drugs located in Houston, Texas. The inspection identified several critical violations regarding sterile processing and facility maintenance. Key issues included personnel performing sterile manipulations with exposed skin and hair, as well as staff manually touching sterile product surfaces. Environmental controls were found lacking, with documented failures in maintaining proper air pressure between cleanrooms and the presence of water leaks and suspected mold near production areas. The firm also failed to properly investigate microbial contamination found in its sterile zones, releasing drug products despite the presence of contaminants. Furthermore, Houston Rx LLC was found using ingredients labeled for "Research and Development Only" or non-pharmaceutical grade materials in its drug formulations, and many ingredients were stored at incorrect temperatures. Sterilization processes for equipment were not validated or verified with biological indicators. These findings were issued under the Federal Food, Drug, and Cosmetic (FD&C) Act, indicating that products may have been prepared under insanitary conditions. The firm is expected to review these observations and implement comprehensive corrective actions. They must provide a written response to the FDA detailing how they will address these deficiencies to ensure the safety and sterility of their pharmaceutical products.